NeuropathyPhase 2MGUSNCT00665652
Study of Lenalidomide as a Treatment for Neuropathy Associated With Monoclonal Gammopathy of Undetermined Significance
A Phase 2 study testing Lenalidomide in people with Neuropathy and Nonmalignant Monoclonal Gammopathy of Undetermined Significance (MGUS), run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
The purpose of the study is to learn about the effects of the drug, lenalidomide (Revlimid®), on neuropathy (damage to the nerves that affect feelings and strength) associated with Nonmalignant Monoclonal Gammopathy of Undetermined Significance (MGUS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuropathy, Nonmalignant Monoclonal Gammopathy of Undetermined Significance (MGUS)
- What is being tested?
- Lenalidomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to 19 May 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically proven MGUS associated neuropathy with a Total Neuropathy Score (TNS) ≥5 (determined by exam, history and confirmatory EDX testing in association with MGUS (IgM,IgG,IgA))
- Disease duration less than or equal to 8 years
- Able to take Plavix 75mg/day or aspirin 325 mg daily as prophylactic anticoagulation. (patients currently taking warfarin with a stable INR may stay on current dose)
Who cannot join
- Patients previously treated with thalidomide
- Patients previously treated with lenalidomide
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
- The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs
- Known positive for HIV or infectious hepatitis, type A, B or C
- Medical history of deep venous thrombosis or hyper-coagulable state
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- Gastrointestinal abnormalities including: inability to take oral medication, requirement for intravenous alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease
- Patients with dementia, other serious neurological diseases, uncompensated medical illness, substance abuse and debilitating psychiatric illness.
- A serious uncontrolled medical disorder or active infection that would impair the patient's ability to receive study treatment. Significant cardiac disease, including uncontrolled high blood pressure, unstable angina, congestive heart failure, myocardial infarction within the previous 6 months or serious cardiac arrhythmias will be excluded.
- Medical conditions associated with neuropathy such as active thyroid disease, diabetes mellitus, and lupus, nutritional deficiencies, malignancy, human immunodeficiency virus infection, alcohol dependence, amyloidosis, or connective tissue diseases and Guillain-Barre Syndrome. Medications or toxic exposures known to cause neuropathy, or a family history of neuropathy will also be grounds for exclusion.
- Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).
- Subjects who are allergic to aspirin or Plavix (clopidogrel)
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
Official title: A Phase II Trial of Lenalidomide as a Treatment for Neuropathy Associated With Nonmalignant Monoclonal Gammopathy of Undetermined Significance (MGUS)
The purpose of the study is to learn about the effects of the drug, lenalidomide (Revlimid®), on neuropathy (damage to the nerves that affect feelings and strength) associated with Nonmalignant Monoclonal Gammopathy of Undetermined Significance (MGUS).
Read the detailed description
Screening:
All subjects eligible for screening must sign an informed consent for the study prior to any study related procedures.
Study Design:
This is an open-label, single-institutional clinical study of lenalidomide as a treatment for MGUS associated neuropathy. Eligible patients will be followed for 28 days before starting study drug. Subjects who remain eligible during the 28 day pretreatment period will receive lenalidomide 25 mg per day for days 1-21 followed by 7 days rest (28-day cycle) for 12 cycles. All patients on treatment will be followed and will be included in the intention to treat group. Patients will be evaluated every three months with the TNS. On-treatment patients must come to clinic at least monthly for the first 3 cycles, and then can come as per the schedule of study assessments only if they are on a stable dose of lenalidomide for at least one cycle. Subjects will be enrolled in the study for up to 14 months.
Lenalidomide administration:
Lenalidomide is an oral medication that will be taken at approximately the same time each day with or without food.
Lenalidomide capsules should be swallowed whole, and should not be broken, chewed or opened.
If a dose of lenalidomide is missed, it should be taken as soon as possible on the same day. If it is missed for the entire day, it should not be made up.
Patients who take more than the prescribed dose of lenalidomide should be instructed to seek emergency medical care if needed and contact study staff immediately.
Dosing Regimen:
The planned dose of lenalidomide for investigation is 25 mg/day, orally on days 1-21 followed by 7 days rest (28 day cycle). Dosing will be in the morning at approximately the same time each day. The planned dose is: Plavix 75mg/day or aspirin 325mg/day.
Subjects experiencing adverse events may need study treatment modifications
- Being tested
- Lenalidomide
- Keywords
- Neuropathy, Nonmalignant Monoclonal Gammopathy of Undetermined Significance (MGUS), MGUS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenalidomideDrug
Subjects will receive lenalidomide 25 mg per day for days 1-21 followed by 7 days rest (28-day cycle) for 12 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Lenalidomide | Experimental | Not described Receives: Drug: Lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Total Neuropathy Score in Subjects With MGUS Associated Neuropathy After Treatment With Lenalidomide.
Minimum value of the Total Neuropathy Score is "0", maximum value is "40". A higher score represents a worsening.
Measured: Baseline, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2008 (estimated)
- Study startApr 2008
- Primary completion19 May 2011
- Study completion19 May 2011
Why it stopped: The study has been suspended for slower than anticipated enrollment to date.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for NeuropathyStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation
- Responsible party
- Principal investigator, Elijah W. Stommel, Dartmouth-Hitchcock Medical Center
- Investigators
- Elijah W. Stommel, MD, PhD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00665652
- Sponsor's protocol ID
- RV-PN-PI-235 D0713
- Acronym
- MGUS
- Status last verified
- Aug 2018
- First submitted
- 22 Apr 2008
- Last updated
- 11 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Lenalidomide as a Treatment for Neuropathy Associated With Nonmalignant Monoclonal Gammopathy of Undetermined Significance (MGUS)
- ClinicalTrials.gov ID
- NCT00665652
- Acronym / sponsor ID
- MGUS / RV-PN-PI-235 D0713
- Keywords
- Neuropathy, Nonmalignant Monoclonal Gammopathy of Undetermined Significance (MGUS), MGUS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study has been suspended for slower than anticipated enrollment to date.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- Celgene Corporation
- Study start
- Apr 2008
- Primary completion
- 19 May 2011 (actual)
- Study completion
- 19 May 2011 (actual)
- First posted
- 24 Apr 2008 (estimated)
- Results
- Posted 11 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to learn about the effects of the drug, lenalidomide (Revlimid®), on neuropathy (damage to the nerves that affect feelings and strength) associated with Nonmalignant Monoclonal Gammopathy of Undetermined Significance (MGUS).
Detailed description
Screening:
All subjects eligible for screening must sign an informed consent for the study prior to any study related procedures.
Study Design:
This is an open-label, single-institutional clinical study of lenalidomide as a treatment for MGUS associated neuropathy. Eligible patients will be followed for 28 days before starting study drug. Subjects who remain eligible during the 28 day pretreatment period will receive lenalidomide 25 mg per day for days 1-21 followed by 7 days rest (28-day cycle) for 12 cycles. All patients on treatment will be followed and will be included in the intention to treat group. Patients will be evaluated every three months with the TNS. On-treatment patients must come to clinic at least monthly for the first 3 cycles, and then can come as per the schedule of study assessments only if they are on a stable dose of lenalidomide for at least one cycle. Subjects will be enrolled in the study for up to 14 months.
Lenalidomide administration:
Lenalidomide is an oral medication that will be taken at approximately the same time each day with or without food.
Lenalidomide capsules should be swallowed whole, and should not be broken, chewed or opened.
If a dose of lenalidomide is missed, it should be taken as soon as possible on the same day. If it is missed for the entire day, it should not be made up.
Patients who take more than the prescribed dose of lenalidomide should be instructed to seek emergency medical care if needed and contact study staff immediately.
Dosing Regimen:
The planned dose of lenalidomide for investigation is 25 mg/day, orally on days 1-21 followed by 7 days rest (28 day cycle). Dosing will be in the morning at approximately the same time each day. The planned dose is: Plavix 75mg/day or aspirin 325mg/day.
Subjects experiencing adverse events may need study treatment modifications
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lenalidomide | Experimental | Drug: Lenalidomide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinically proven MGUS associated neuropathy with a Total Neuropathy Score (TNS) ≥5 (determined by exam, history and confirmatory EDX testing in association with MGUS (IgM,IgG,IgA))
- Disease duration less than or equal to 8 years
- Able to take Plavix 75mg/day or aspirin 325 mg daily as prophylactic anticoagulation. (patients currently taking warfarin with a stable INR may stay on current dose)
Key exclusion criteria (12 listed)
- Patients previously treated with thalidomide
- Patients previously treated with lenalidomide
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
- The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs
- Known positive for HIV or infectious hepatitis, type A, B or C
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 |
|---|---|---|
| LenalidomideSubjects will receive lenalidomide 25 mg per day for days 1-21 followed by 7 days rest (28-day cycle) for 12 cycles. | Drug | Lenalidomide |
Primary outcome
Change in Total Neuropathy Score in Subjects With MGUS Associated Neuropathy After Treatment With Lenalidomide.
Time frame: Baseline, 12 months
Minimum value of the Total Neuropathy Score is "0", maximum value is "40". A higher score represents a worsening.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Elijah W. Stommel, MD, PhD principal investigator
Dartmouth-Hitchcock Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lenalidomide in people with Neuropathy and Nonmalignant Monoclonal Gammopathy of Undetermined Significance (MGUS), run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
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 3 inclusion and 12 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: stopped early, as of the sponsor's last update on 11 Sep 2018. 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Total Neuropathy Score in Subjects With MGUS Associated Neuropathy After Treatment With Lenalidomide. (time frame: Baseline, 12 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 11 Sep 2018.