Back to resultsEvaluation of Bortezomib Induced Peripheral Neuropathy of Multiple Myeloma (MM) Patients
Primary Purpose
Multiple Myeloma, Peripheral Neuropathy
Status
Unknown status
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
EMG
Sponsored by
About this trial
This is an interventional diagnostic trial for Multiple Myeloma focused on measuring 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
Eligibility 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
Sites / Locations
- Wolfson MC
Outcomes
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.
Secondary Outcome Measures
To accommodate the dose of bortezomib with the progression of Peripheral Neuropathy
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00872352
Brief Title
Evaluation of Bortezomib Induced Peripheral Neuropathy of Multiple Myeloma (MM) Patients
Official Title
Phase 3 Study to Evaluate Bortezomib Induced Peripheral Neuropathy of Multiple Myeloma (MM) Patients.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Unknown status
Study Start Date
April 2009 (undefined)
Primary Completion Date
July 2009 (Anticipated)
Study Completion Date
August 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Wolfson Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
EMG
Intervention Description
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 Measure Information:
Title
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 Measure Information:
Title
To accommodate the dose of bortezomib with the progression of Peripheral Neuropathy
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Husam Ghoti, MD
Phone
972-35028778
Email
drghoti123@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eliezer Rachmilewitz, MD
Organizational Affiliation
Head of Hematology, Wolfson MC, Holon, Israel
Official's Role
Study Director
Facility Information:
Facility Name
Wolfson MC
City
Holon
ZIP/Postal Code
58100
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Husam Ghoti, MD
Phone
972-5028778
Email
drghoti123@yahoo.com
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Bortezomib Induced Peripheral Neuropathy of Multiple Myeloma (MM) Patients
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