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The Pathophysiology of Bortezomib Induced Peripheral Neuropathy (BIPN)

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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
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease
Multiple Myeloma

Detailed Description:

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 Design

Study Type : Observational
Estimated Enrollment : 30 participants
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?
Study Start Date : August 2010
Estimated Primary Completion Date : August 2011
Estimated Study Completion Date : August 2011


Groups and Cohorts


Outcome Measures

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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).
Criteria

Inclusion Criteria:

  1. 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:

  1. Patients with relapsed or progressive multiple myeloma.
  2. Performance status > 2.
  3. Prior treatment with neuropathic agents such as Oncovin and thalidomide.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01171443


Contacts
Contact: Ghoti Hossam 035028110 drghoti123@yahoo.com

Locations
Israel
Wolfsson Medical Center Not yet recruiting
Holon, Israel
Contact: GHOTI HOSSAM    970-35028110    drghoti123@yahoo.com   
Sponsors and Collaborators
Wolfson Medical Center
Investigators
Principal Investigator: GHOTI HOSSAM HEMATOLOGY DEPARTMENT ON WOLFSSON MEDICAL CENTER
More Information

Responsible Party: Dr' Ghoti Hossam, hematology department on Wolfsson Medical Center
ClinicalTrials.gov Identifier: NCT01171443     History of Changes
Other Study ID Numbers: 0102-10CTIL
First Posted: July 28, 2010    Key Record Dates
Last Update Posted: July 28, 2010
Last Verified: July 2010

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