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

Multiple Myeloma Clinical Trial

Official title:

Phase 3 Study to Evaluate Bortezomib Induced Peripheral Neuropathy of Multiple Myeloma (MM) Patients.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00872352
• Other study ID #: Version 1.1
• Status: Not yet recruiting
• Phase: Phase 3
• First received: March 30, 2009
• Last updated: March 30, 2009
• Start date: April 2009
• Est. completion date: August 2009

Study information

• Verified date: March 2009
• Source: Wolfson Medical Center
• Contact: Husam Ghoti, MD
• Phone: 972-35028778
• Email: drghoti123[@]yahoo.com
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: August 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Peripheral Nervous System Diseases
• Peripheral Neuropathy

Intervention

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

Locations

Country	Name	City	State
Israel	Wolfson MC	Holon

Sponsors (1)

Lead Sponsor	Collaborator
Wolfson Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	To accommodate the dose of bortezomib with the progression of Peripheral Neuropathy		4 months	Yes