Know Cancer

forgot password

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

Phase 3
18 Years
75 Years
Not Enrolling
Multiple Myeloma, Peripheral Neuropathy

Thank you

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

- 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:


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:


Principal Investigator

Eliezer Rachmilewitz, MD

Investigator Role:

Study Director

Investigator Affiliation:

Head of Hematology, Wolfson MC, Holon, Israel


Israel: Ethics Commission

Study ID:

Version 1.1



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