POEMS SyndromePhase 2NCT00971685
The Treatment of Lenalidomide in Patients With POEMS Syndrome
A Phase 2 study testing Lenalidomide and dexamethasone in people with POEMS Syndrome, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial summary
Lenalidomide is a immunomodulatory drug derived from thalidomide, without neurotoxicity. Lenalidomide blocks the increased secretion of interleukin-6, tumor necrosis factor alpha and vascular endothelial growth factor (VEGF). The association with dexamethasone increased Lenalidomide response rate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- POEMS Syndrome
- What is being tested?
- Lenalidomide and dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2009to Jul 2011
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a diagnosis of POEMS syndrome based on published diagnostic criteria
Who cannot join
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Istituto Clinco Humanitas
Rozzano, Milano, 20089
Andrea Nozza, MD, +39028224 ext. 4080, andrea.nozza@humanitas.it
Andrea Nozza, MD
About this study
Official title: Evaluation of Efficacy and Safety of Lenalidomide (Revlimid®) in Patients With POEMS Syndrome
Lenalidomide is a immunomodulatory drug derived from thalidomide, without neurotoxicity. Lenalidomide blocks the increased secretion of interleukin-6, tumor necrosis factor alpha and vascular endothelial growth factor (VEGF). The association with dexamethasone increased Lenalidomide response rate.
More recently the efficacy of Lenalidomide has been reported in a patient with POEMS (POEMS:polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes) syndrome with improvement of clinical condition and reduction of vascular endothelial growth factor (VEGF) and interleukin-6 (IL-6) level.
- Conditions
- POEMS Syndrome
- Being tested
- Lenalidomide and dexamethasone
- 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 and dexamethasoneDrug
RD regimen: Lenalidomide 25 mg/die for 21 days every month for 6 cycles, with once-weekly dexamethasone (40 mg).
| Study group | Role | What they receive |
|---|---|---|
| Lenalidomide plus Dexamethasone | Experimental | RD regimen: Lenalidomide 25 mg/die for 21 days every month for 6 cycles, with once-weekly dexamethasone (40 mg). Receives: Drug: Lenalidomide and dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of clinical efficacy of Lenalidomide for 21 days every month for 6 cycles, with once-weekly dexamethasone (40 mg)) in patients with POEMS syndrome after 6 cycles.
Measured: one year
Secondary outcomes (1)
Evaluation of the safety and the activity.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2009 (estimated)
- Study startJul 2009
- Primary completionDec 2009
- Study completionJul 2011 (estimated)
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.
- More trials run by Istituto Clinico HumanitasThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Investigators
- Armando Santoro, MD, Principal investigator, Istituto Clinico Humanitas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00971685
- Sponsor's protocol ID
- ONC-2008-002
- Status last verified
- Sep 2010
- First submitted
- 3 Sep 2009
- Last updated
- 2 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficacy and Safety of Lenalidomide (Revlimid®) in Patients With POEMS Syndrome
- ClinicalTrials.gov ID
- NCT00971685
- Acronym / sponsor ID
- ONC-2008-002
- Conditions
- POEMS Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jul 2011 (estimated)
- First posted
- 4 Sep 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.
Lenalidomide is a immunomodulatory drug derived from thalidomide, without neurotoxicity. Lenalidomide blocks the increased secretion of interleukin-6, tumor necrosis factor alpha and vascular endothelial growth factor (VEGF). The association with dexamethasone increased Lenalidomide response rate.
More recently the efficacy of Lenalidomide has been reported in a patient with POEMS (POEMS:polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes) syndrome with improvement of clinical condition and reduction of vascular endothelial growth factor (VEGF) and interleukin-6 (IL-6) level.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lenalidomide plus Dexamethasone | Experimental | Drug: Lenalidomide and dexamethasoneRD regimen: Lenalidomide 25 mg/die for 21 days every month for 6 cycles, with once-weekly dexamethasone (40 mg). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with a diagnosis of POEMS syndrome based on published diagnostic criteria
Key exclusion criteria (1 listed)
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form
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 and dexamethasoneRD regimen: Lenalidomide 25 mg/die for 21 days every month for 6 cycles, with once-weekly dexamethasone (40 mg). | Drug | Lenalidomide plus Dexamethasone |
Primary outcome
Evaluation of clinical efficacy of Lenalidomide for 21 days every month for 6 cycles, with once-weekly dexamethasone (40 mg)) in patients with POEMS syndrome after 6 cycles.
Time frame: one year
1 secondary outcome
Evaluation of the safety and the activity.
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2010.
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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.
Armando Santoro, MD principal investigator
Istituto Clinico Humanitas
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 and dexamethasone in people with POEMS Syndrome, run by Istituto Clinico Humanitas at 1 site in Italy.
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 1 inclusion and 1 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 2 Sep 2010. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Armando Santoro, MD (+39028224 ext. 4080, armando.santoro@humanitas.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of clinical efficacy of Lenalidomide for 21 days every month for 6 cycles, with once-weekly dexamethasone (40 mg)) in patients with POEMS syndrome after 6 cycles. (time frame: one year). 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 2 Sep 2010.