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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Wolfson Medical Center.
Recruitment status was  Not yet recruiting
Information provided by:
Wolfson Medical Center
ClinicalTrials.gov Identifier:
First received: March 30, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
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 Intervention Phase
Multiple Myeloma
Peripheral Neuropathy
Procedure: EMG
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Phase 3 Study to Evaluate Bortezomib Induced Peripheral Neuropathy of Multiple Myeloma (MM) Patients.

Resource links provided by NLM:

Further study details as provided by Wolfson Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To accommodate the dose of bortezomib with the progression of Peripheral Neuropathy [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: April 2009
Estimated Study Completion Date: August 2009
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00872352

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

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

Responsible Party: HusamGhoti, MD, Hematology Dept., Wolfson MC
ClinicalTrials.gov Identifier: NCT00872352     History of Changes
Other Study ID Numbers: Version 1.1 
Study First Received: March 30, 2009
Last Updated: March 30, 2009
Health Authority: Israel: Ethics Commission

Keywords provided by Wolfson Medical Center:
Multiple Myeloma
Peripheral Neuropathy
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
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Nervous System Diseases
Neuromuscular Diseases
Vascular Diseases
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 26, 2016