The Pathophysiology of Bortezomib Induced Peripheral Neuropathy (BIPN)
Recruitment status was Not yet recruiting
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Purpose
Since the pathophysiology of BIPN still remains unclear, in the present study we are going to assess the development of BIPN in newly diagnosed myeloma patients, based on clinical neurological examination and electrophysiological study (EMG) and trying to find out if there is any relationship between oxidative stress generation measured by serum malonyldialdehyde - (MDA) and urinary isoprostane, and the development of BIPN, which can explain important part of the BIPN pathophysiology and can suggest new ideas of treatment and prophylactic strategies of peripheral neuropathy.
| Condition |
|---|
|
Multiple Myeloma |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Is There a Role of Oxidative Stress in the Pathophysiology of Bortezomib Induced Peripheral Neuropathy (BIPN) in Multiple Myeloma Patients? |
| Estimated Enrollment: | 30 |
| Study Start Date: | August 2010 |
| Estimated Study Completion Date: | August 2011 |
| Estimated Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
A total of 30 newly diagnosed patients (age > 18 years) with multiple myeloma (stage3 Durie and Salmon, ECOG-performance status <2), who are candidates for bortezomib therapy will be enrolled in the study (duration of the study 6 months).
Inclusion Criteria:
- A total of 30 newly diagnosed patients (age > 18 years) with multiple myeloma (stage3 Durie and Salmon, ECOG-performance status <2), who are candidates for bortezomib therapy will be enrolled in the study (duration of the study 6 months).
Exclusion Criteria:
- Patients with relapsed or progressive multiple myeloma.
- Performance status > 2.
- Prior treatment with neuropathic agents such as Oncovin and thalidomide.
Contacts and Locations| Contact: Ghoti Hossam | 035028110 | drghoti123@yahoo.com |
| Israel | |
| Wolfsson Medical Center | Not yet recruiting |
| Holon, Israel | |
| Contact: GHOTI HOSSAM 970-35028110 drghoti123@yahoo.com | |
| Principal Investigator: | GHOTI HOSSAM | HEMATOLOGY DEPARTMENT ON WOLFSSON MEDICAL CENTER |
More Information
No publications provided
| Responsible Party: | Dr' Ghoti Hossam, hematology department on Wolfsson Medical Center |
| ClinicalTrials.gov Identifier: | NCT01171443 History of Changes |
| Other Study ID Numbers: | 0102-10CTIL |
| Study First Received: | July 27, 2010 |
| Last Updated: | July 27, 2010 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Multiple Myeloma Neoplasms, Plasma Cell Peripheral Nervous System Diseases Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders |
Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Neuromuscular Diseases Nervous System Diseases Bortezomib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on October 17, 2012
