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
Sponsor:
Information provided by:
Wolfson Medical Center
ClinicalTrials.gov Identifier:
NCT00872352
First received: March 30, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  Purpose

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
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
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:
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

ClinicalTrials.gov processed this record on August 26, 2014