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

Wolfson Medical Center (WMC)

Status and phase: Unknown; Phase 3

Conditions: Peripheral Neuropathy; Multiple Myeloma

Treatments: Procedure: EMG

Study type: Interventional

Funder types: Other

Identifiers

NCT00872352

Version 1.1

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)