Evaluation of Bortezomib Induced Peripheral Neuropathy of Multiple Myeloma (MM) Patients
Phase 3
- Conditions
- Multiple MyelomaPeripheral Neuropathy
- Registration Number
- NCT00872352
- Lead Sponsor
- Wolfson Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method To accommodate the dose of bortezomib with the progression of Peripheral Neuropathy 4 months
Trial Locations
- Locations (1)
Wolfson MC
🇮🇱Holon, Israel