POEMS SyndromePhase 2NCT02193698
Efficacy and Safety of Lenalidomide as a Treatment for Recurrent or Refractory POEMS Syndrome Trial
A Phase 2 study testing Lenalidomide+Dexamethasone in people with POEMS Syndrome, run by Chiba University at 1 site in Japan.
Trial summary
This study investigates the efficacy and safety of Lenalidomide as a treatment for recurrent or refractory POEMS (Crow-Fukase) syndrome. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- POEMS Syndrome
- What is being tested?
- Lenalidomide+Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteJapan
- Study dates
- Jul 2014to Apr 2016
- Phase
- Phase 2
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Crow-Fukase syndrome (confirmed by diagnostic criteria.)
- Recurrent or refractory Crow-Fukase syndrome.
- Patients without severe liver or renal dysfunction.
- Patients without severe neutropenia or thrombocytopenia.
- Patients without clinically problematic ECG findings
- Negative on the pregnacy test on the day 1 of cycle 1.
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- Patients who can undertake prevention of pregnancy, if necessary.
- Patients with written informed consent.
- Patients who are capable of ambulatory hospital visits every 4 weeks.
- Patients with informed consent to the registration and rules of RevMate®.
Who cannot join
- Patients who have been administered, bortezomib, lenalidomide, melpharan within 4 weeks prior to the registration.
- Patients who have been on steroid treatment (more than 10mg/day in predonine) within 2 weeks prior to the registration.
- Patients who have been administered bevacizumab within 12 weeks prior to the registration.
- Patients who could worsen acutely during the clinical trial period.
- Patients with severe complicaitons ( cardiac failure, renal failure liver failure, bleeding enterogastric ulcer, ileus, poorly controlled diabetes.
- Patients with malignancies.
- Female patients who are pregnant or desire childbearing. Males who desire fertility.
- Patients who allergic to lenalidomide or dexamethasone.
Trial locations and contacts
1 site in 1 country.
Japan1 site
Chiba University Graduate School of Medicine Department of neurology
Chiba, Chiba, 260-8760
About this study
Official title: Single Arm Open-label Trial to Investigate the Efficacy and Safety of Lenlidomide as a Treatment for Recurrent or Refractory Crow-Fukase (POEMS) Syndrome
This study investigates the efficacy and safety of Lenalidomide as a treatment for recurrent or refractory POEMS (Crow-Fukase) syndrome.
Read the detailed description
This study investigates the efficacy and safety of Lenalidomide as a treatment for recurrent /refractory POEMS (Crow-Fukase) syndrome.
- Conditions
- POEMS Syndrome
- Being tested
- Lenalidomide+Dexamethasone
- Keywords
- POEMS syndrome, lenalidomide
- Medical subject headings
- POEMS Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lenalidomide+DexamethasoneDrug
Also called Lebramide+Decadoron
Lenalidomide 25mg/day (day 1-21) Dexamethasone 20mg/day (day 2. 9, 16, 23)
| Study group | Role | What they receive |
|---|---|---|
| Lenalidomide+Dexamethasone | Experimental | Cycle1 : Lenalidomide 15mg/day (day 1-21) Cycle2-6 : Lenalidomide 25mg/day (day 1-21) Dexamethasone 20mg/day (day 2. 9, 16, 23) Receives: Drug: Lenalidomide+Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction rate of serum VEGF
Measured: after 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionOct 2015
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for POEMS SyndromeStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiba University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sonoko Misawa, Chiba University
- Investigators
- Sonoko Misawa, MD, Principal investigator, Chiba University, Department of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02193698
- Sponsor's protocol ID
- G26007
- Status last verified
- Jul 2016
- First submitted
- 16 Jul 2014
- Last updated
- 29 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Arm Open-label Trial to Investigate the Efficacy and Safety of Lenlidomide as a Treatment for Recurrent or Refractory Crow-Fukase (POEMS) Syndrome
- ClinicalTrials.gov ID
- NCT02193698
- Acronym / sponsor ID
- G26007
- Conditions
- POEMS Syndrome
- Keywords
- POEMS syndrome, lenalidomide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Chiba UniversityUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 18 Jul 2014 (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.
This study investigates the efficacy and safety of Lenalidomide as a treatment for recurrent or refractory POEMS (Crow-Fukase) syndrome.
Detailed description
This study investigates the efficacy and safety of Lenalidomide as a treatment for recurrent /refractory POEMS (Crow-Fukase) syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lenalidomide+Dexamethasone | Experimental | Drug: Lenalidomide+DexamethasoneCycle1 : Lenalidomide 15mg/day (day 1-21) Cycle2-6 : Lenalidomide 25mg/day (day 1-21) Dexamethasone 20mg/day (day 2. 9, 16, 23) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with Crow-Fukase syndrome (confirmed by diagnostic criteria.)
- Recurrent or refractory Crow-Fukase syndrome.
- Patients without severe liver or renal dysfunction.
- Patients without severe neutropenia or thrombocytopenia.
- Patients without clinically problematic ECG findings
Key exclusion criteria (8 listed)
- Patients who have been administered, bortezomib, lenalidomide, melpharan within 4 weeks prior to the registration.
- Patients who have been on steroid treatment (more than 10mg/day in predonine) within 2 weeks prior to the registration.
- Patients who have been administered bevacizumab within 12 weeks prior to the registration.
- Patients who could worsen acutely during the clinical trial period.
- Patients with severe complicaitons ( cardiac failure, renal failure liver failure, bleeding enterogastric ulcer, ileus, poorly controlled diabetes.
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 |
|---|---|---|
| Lenalidomide+DexamethasoneAlso: Lebramide+DecadoronLenalidomide 25mg/day (day 1-21) Dexamethasone 20mg/day (day 2. 9, 16, 23) | Drug | Lenalidomide+Dexamethasone |
Primary outcome
Reduction rate of serum VEGF
Time frame: after 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2016.
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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.
Sonoko Misawa, MD principal investigator
Chiba University, Department of Neurology
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+Dexamethasone in people with POEMS Syndrome, run by Chiba University at 1 site in Japan.
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 10 inclusion and 8 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: finished, as of the sponsor's last update on 29 Jul 2016. 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 Japan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reduction rate of serum VEGF (time frame: after 24 weeks). 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 29 Jul 2016.