Evaluation of Bortezomib Induced Peripheral Neuropathy of... | NCT00872352

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

NCT00872352

Sponsor

Wolfson Medical Center

Status

Unknown status

Last Update Posted

Mar 31, 2009Estimated

Enrollment

30Estimated

Phase

Phase 3

Conditions

Multiple Myeloma
Peripheral Neuropathy

Interventions

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2009

Primary Completion Date

Jul 2009Estimated

Completion Date

Aug 2009Estimated

First Submitted Date

Mar 30, 2009

First Submission Date that Met QC Criteria

Mar 30, 2009

First Posted Date

Mar 31, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 30, 2009

Last Update Posted Date

Mar 31, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Conditions Module

Conditions

Multiple Myeloma
Peripheral Neuropathy

Keywords

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
EMG	Procedure	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
To accommodate the dose of bortezomib with the progression of Peripheral Neuropathy		4 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Husam Ghoti, MD	Contact	972-35028778		drghoti123@yahoo.com

Overall Officials

Name	Affiliation	Role
Eliezer Rachmilewitz, MD	Head of Hematology, Wolfson MC, Holon, Israel	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Wolfson MC		Holon	Holon	58100	Israel

Condition Browse Module

MeSH Terms

ID	Term
D009101	Multiple Myeloma
D010523	Peripheral Nervous System Diseases

Ancestor Terms

ID	Term
D054219	Neoplasms, Plasma Cell
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D020141	Hemostatic Disorders

Browse Leaves

Not provided

Browse Branches

Not provided