Multiple MyelomaPhase 3NCT00872352
Evaluation of Bortezomib Induced Peripheral Neuropathy of Multiple Myeloma (MM) Patients
A Phase 3 study testing EMG in people with Multiple Myeloma and Peripheral Neuropathy, run by Wolfson Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Multiple Myeloma, Peripheral Neuropathy
- What is being tested?
- EMG
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2009to Aug 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Multiple Myeloma on progression
- Incidence of Relapsed or Refractory Myeloma
- Patients with the existing neuropathy at the time of the diagnosis
Trial locations and contacts
1 site in 1 country.
Israel1 site
Wolfson MC
Holon, Holon, 58100
Husam Ghoti, MD, 972-5028778, drghoti123@yahoo.com
About this study
Official title: Phase 3 Study to Evaluate Bortezomib Induced Peripheral Neuropathy of Multiple Myeloma (MM) Patients.
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.
- Conditions
- Multiple Myeloma, Peripheral Neuropathy
- Being tested
- EMG
- 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
- Medical subject headings
- Multiple Myeloma, Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMGProcedure or surgery
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (1)
To accommodate the dose of bortezomib with the progression of Peripheral Neuropathy
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2009 (estimated)
- Study startApr 2009
- Primary completionJul 2009 (estimated)
- Study completionAug 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wolfson Medical Center
- Sponsor type
- Other government
- Investigators
- Eliezer Rachmilewitz, MD, Study director, Head of Hematology, Wolfson MC, Holon, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00872352
- Sponsor's protocol ID
- Version 1.1
- Status last verified
- Mar 2009
- First submitted
- 30 Mar 2009
- Last updated
- 31 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study to Evaluate Bortezomib Induced Peripheral Neuropathy of Multiple Myeloma (MM) Patients.
- ClinicalTrials.gov ID
- NCT00872352
- Acronym / sponsor ID
- Version 1.1
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Wolfson Medical CenterOther government
- Study start
- Apr 2009
- Primary completion
- Jul 2009 (estimated)
- Study completion
- Aug 2009 (estimated)
- First posted
- 31 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Multiple Myeloma on progression
- Incidence of Relapsed or Refractory Myeloma
- Patients with the existing neuropathy at the time of the diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMGNerve 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 | Procedure or surgery | – |
Primary outcome
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
1 secondary outcome
To accommodate the dose of bortezomib with the progression of Peripheral Neuropathy
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eliezer Rachmilewitz, MD study director
Head of Hematology, Wolfson MC, Holon, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing EMG in people with Multiple Myeloma and Peripheral Neuropathy, run by Wolfson Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Husam Ghoti, MD (972-35028778, drghoti123@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary 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. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2009.