Status:

UNKNOWN

The Pathophysiology of Bortezomib Induced Peripheral Neuropathy

Lead Sponsor:

Wolfson Medical Center

Conditions:

Multiple Myeloma

Eligibility:

All Genders

18+ years

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 examina...

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 sign...

Eligibility Criteria

Inclusion

  • 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

  • Patients with relapsed or progressive multiple myeloma.
  • Performance status \> 2.
  • Prior treatment with neuropathic agents such as Oncovin and thalidomide.

Key Trial Info

Start Date :

August 1 2010

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

August 1 2011

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT01171443

Start Date

August 1 2010

End Date

August 1 2011

Last Update

July 28 2010

Active Locations (1)

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Wolfsson Medical Center

Holon, Israel, Israel