Phase 3 Study to Evaluate Bortezomib Induced Peripheral Neuropathy of Multiple Myeloma (MM) Patients.
Phase 3
18 Years
75 Years
18 Years
75 Years
Not Enrolling
Both
Multiple Myeloma, Peripheral Neuropathy
Both
Multiple Myeloma, Peripheral Neuropathy
Trial Information
Phase 3 Study to Evaluate Bortezomib Induced Peripheral Neuropathy of Multiple Myeloma (MM) Patients.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
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.
Outcome Time Frame:
3 months
Safety Issue:
Yes
Principal Investigator
Eliezer Rachmilewitz, MD
Investigator Role:
Study Director
Investigator Affiliation:
Head of Hematology, Wolfson MC, Holon, Israel
Authority:
Israel: Ethics Commission
Study ID:
Version 1.1
NCT ID:
NCT00872352
Start Date:
April 2009
Completion Date:
August 2009
Related Keywords:
- Multiple Myeloma
- Peripheral Neuropathy
- 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
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Peripheral Nervous System Diseases
- Demyelinating Diseases
- Polyneuropathies
- Nerve Compression Syndromes
- Neurologic Manifestations
- Neurotoxicity Syndromes
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