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

NCT00872352 | Unknown Phase 3

• 1 other identifier: Version 1.1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma; Peripheral Neuropathy

Keywords

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

Outcome Measures

Primary Outcomes (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.

  3 months

Secondary Outcomes (1)

• To accommodate the dose of bortezomib with the progression of Peripheral Neuropathy

  4 months

Interventions

EMG PROCEDURE

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 Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Wolfson Medical Center: lead

Study Sites (1)

Wolfson MC

Holon, Holon, 58100, Israel

Location

MeSH Terms

Conditions

Multiple Myeloma; Peripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Eliezer Rachmilewitz, MD

  Head of Hematology, Wolfson MC, Holon, Israel

  STUDY DIRECTOR

Central Study Contacts

Husam Ghoti, MD

CONTACT

972-35028778; drghoti123@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: March 30, 2009
• First Posted: March 31, 2009
• Study Start: April 1, 2009
• Primary Completion: July 1, 2009
• Study Completion: August 1, 2009
• Last Updated: March 31, 2009

Record last verified: 2009-03

Locations

IL (1)