Evaluation of Bortezomib Induced Peripheral Neuropathy of Multiple Myeloma (MM) Patients
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Wolfson Medical Center.
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
Wolfson Medical Center
Information provided by:
Wolfson Medical Center
ClinicalTrials.gov Identifier:
NCT00872352
First received: March 30, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma Peripheral Neuropathy |
Procedure: EMG |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Phase 3 Study to Evaluate Bortezomib Induced Peripheral Neuropathy of Multiple Myeloma (MM) Patients. |
Resource links provided by NLM:
Genetics Home Reference related topics:
Charcot-Marie-Tooth disease
hereditary neuropathy with liability to pressure palsies
Drug Information available for:
Bortezomib
U.S. FDA Resources
Further study details as provided by Wolfson Medical Center:
Primary Outcome Measures:
- 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. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To accommodate the dose of bortezomib with the progression of Peripheral Neuropathy [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 30 |
| Study Start Date: | April 2009 |
| Estimated Study Completion Date: | August 2009 |
| Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Procedure: 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
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00872352
Contacts
| Contact: Husam Ghoti, MD | 972-35028778 | drghoti123@yahoo.com |
Locations
| Israel | |
| Wolfson MC | Not yet recruiting |
| Holon, Israel, 58100 | |
| Contact: Husam Ghoti, MD 972-5028778 drghoti123@yahoo.com | |
Sponsors and Collaborators
Wolfson Medical Center
Investigators
| Study Director: | Eliezer Rachmilewitz, MD | Head of Hematology, Wolfson MC, Holon, Israel |
More Information
No publications provided
| Responsible Party: | HusamGhoti, MD, Hematology Dept., Wolfson MC |
| ClinicalTrials.gov Identifier: | NCT00872352 History of Changes |
| Other Study ID Numbers: | Version 1.1 |
| Study First Received: | March 30, 2009 |
| Last Updated: | March 30, 2009 |
| Health Authority: | Israel: Ethics Commission |
Keywords provided by Wolfson Medical Center:
|
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 |
Additional relevant MeSH terms:
|
Multiple Myeloma Neoplasms, Plasma Cell Peripheral Nervous System Diseases Demyelinating Diseases Polyneuropathies Nerve Compression Syndromes Neurologic Manifestations Neurotoxicity Syndromes Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders |
Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Neuromuscular Diseases Nervous System Diseases Signs and Symptoms Poisoning Substance-Related Disorders Bortezomib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protease Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013