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Evaluation of Bortezomib Induced Peripheral Neuropathy of Multiple Myeloma (MM) Patients

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ClinicalTrials.gov Identifier: NCT00872352
Recruitment Status : Unknown
Verified March 2009 by Wolfson Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : March 31, 2009
Last Update Posted : March 31, 2009
Sponsor:
Information provided by:
Wolfson Medical Center

Brief Summary:
In the present study we are planning to study electrophysiological changes related to the dose and time of bortezomib administration in newly diagnosed patients with MM, during the first months of treatment and 6 months after ending. In addition a possible correlation between the incidence of BIPN and the subtype of myeloma and other risk factors will be investigated.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Peripheral Neuropathy Procedure: EMG Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Phase 3 Study to Evaluate Bortezomib Induced Peripheral Neuropathy of Multiple Myeloma (MM) Patients.
Study Start Date : April 2009
Estimated Primary Completion Date : July 2009
Estimated Study Completion Date : August 2009



Intervention Details:
    Procedure: EMG
    Nerve conduction study will be consisted of sequential evaluation of the motor nerves: median, ulnar, peroneal and tibial; and the sensory nerves: median, ulnar, superficial peroneal and sural nerves using a standardized protocol


Primary Outcome Measures :
  1. A dose-related neurotoxic effect of bortezomib will be determined through regression analysis with the change in TNSr as the dependent variable Bortezomib doses will use as independent variables. [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. To accommodate the dose of bortezomib with the progression of Peripheral Neuropathy [ Time Frame: 4 months ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age> 18
  • Patients with Multiple Myeloma stage II, III (Durie and Salmon staging) prior to Bortezomib Therapy
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
  • Be willing and able to comply with the protocol treatment for the duration of the study
  • Patient's written informed consent

Exclusion Criteria:

  • Multiple Myeloma on progression
  • Incidence of Relapsed or Refractory Myeloma
  • Patients with the existing neuropathy at the time of the diagnosis

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): NCT00872352


Contacts
Contact: Husam Ghoti, MD 972-35028778 drghoti123@yahoo.com

Locations
Israel
Wolfson MC Not yet recruiting
Holon, Israel, 58100
Contact: Husam Ghoti, MD    972-5028778    drghoti123@yahoo.com   
Sponsors and Collaborators
Wolfson Medical Center
Investigators
Study Director: Eliezer Rachmilewitz, MD Head of Hematology, Wolfson MC, Holon, Israel

Responsible Party: HusamGhoti, MD, Hematology Dept., Wolfson MC
ClinicalTrials.gov Identifier: NCT00872352     History of Changes
Other Study ID Numbers: Version 1.1
First Posted: March 31, 2009    Key Record Dates
Last Update Posted: March 31, 2009
Last Verified: March 2009

Keywords provided by Wolfson Medical Center:
Multiple Myeloma
Bortezomib
Peripheral Neuropathy
evaluation
evaluation of electrophysiological changes related to the dose and time of bortezomib administration
investigation of correlation between the incidence of BIPN and the subtype of myeloma

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Multiple Myeloma
Neoplasms, Plasma Cell
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