MedDataX Logo

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

NCT ID: NCT00872352

Last Updated: 2009-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2009-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Multiple Myeloma Peripheral Neuropathy

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

EMG

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Wolfson Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hematology Dept., Wolfson MC

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Eliezer Rachmilewitz, MD

Role: STUDY_DIRECTOR

Head of Hematology, Wolfson MC, Holon, Israel

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Wolfson MC

Holon, Holon, Israel

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Israel

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Husam Ghoti, MD

Role: CONTACT

Phone: 972-35028778

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Husam Ghoti, MD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Version 1.1

Identifier Type: -

Identifier Source: org_study_id