POEMS SyndromePhase 2POEMSNCT01639898
POEMS Syndrome Treatment With Lenalidomide
A Phase 2 study testing Lenalidomide and dexamethasone in people with POEMS Syndrome, run by University Hospital, Limoges at 11 sites in France.
Trial summary
POEMS syndrome is a rare form of B cell dyscrasia combining a proliferation usually of plasma cells, a polyneuropathy, osteocondensing bone lesions and multiple other clinical signs. Lenalidomide appears to be particularly efficient in this pathology. 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
- 51 participants
- Where
- 11 sitesFrance
- Study dates
- Jul 2012to Jul 2018
- 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 suffering from POEMS syndrome (Mayo Clinic criteria)
- Patients with a localised disease who can be treated with radiation and those with a disseminated disease and who can be treated intensively will be included in Group 1, all other patients will be included in Group 2.
- Patients aged of 18 or more
- Patients who do not show uncontrolled thrombosis
- Patients who have been duly informed and who have signed a consent form.
- Patients must respect all the lenalidomide Pregnancy Prevention Program (PPP) requirements described in appendix of the protocol.
- Patients registered with the French National Health System.
Who cannot join
- Women who are pregnant, or suspected to be pregnant or breastfeeding
- Pathology not linked with POEMS, contraindicating one of the studied drugs
- Patients suffering from a deficiency which does not allow them full understanding of the trial requirements and which could compromise proper consent from the patient and/or observance of the protocol and continuous participation in the trial.
- Prior history of malignancy other than POEMS syndrome or active other cancer or other serious illness.
- Any contraindication to Revlimid® or to one of its excipient.
- Patient with clearance creatinine < 30mL/min.
Show all 14Show fewer
- Hepatic insufficiency
- Patient with Absolute Neutrophil count (ANC) < 1,0 x 109/L
- Patient with platelet count < 75 x 109/L
- Use of any other experimental drug or therapy within 28 days of baseline
- Known hypersensitivity to thalidomide
- Instable, clinically significant ECG findings
- Known positive for HIV, or active infectious hepatitis, type A, B or C
- Patients under protection of a legal order.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
CHU d'Angers
Angers, 49933
CHU de Caen
Caen, 14000
CHU de Lille
Lille, 59037
CHU de Limoges
Limoges, 87042
Hospices Civil de Lyon
Lyon, 69000
Centre Léon Bérard
Lyon, 69373
CHU de Nantes
Nantes, 44093
Hôpital Saint-Louis
Paris, 75010
Pitié Salpétrière
Paris, 75013
Hôpital Necker
Paris, 75743
CHU de Toulouse
Toulouse, 31059
About this study
Official title: Phase II Trial With Lenalidomide-Dexamethasone Combination in the Treatment of POEMS Syndrome.
POEMS syndrome is a rare form of B cell dyscrasia combining a proliferation usually of plasma cells, a polyneuropathy, osteocondensing bone lesions and multiple other clinical signs. Lenalidomide appears to be particularly efficient in this pathology.
The investigators propose a phase II multicentre protocol, based on the use of lenalidomide combined with dexamethasone in patients presenting a POEMS syndrome, either de novo or resistant or in relapse.
Read more
Patients who can be treated by local radiation or intensive treatment with stem cell support will undergo 2 cycles of the lenalidomide-dexamethasone (Len-Dex) combination before radiation or intensive treatment (Group 1), the other patients will undergo 9 cycles of the Len-Dex combination (Group 2).
A biological study is coupled with this clinical protocol in order to define the best biological markers predicting clinical responses, to better understand the POEMS pathophysiological mechanisms and to set up a bank of samples which can be used to study this rare pathology.
Read the detailed description
The investigators propose to simultaneously set up two Phase II therapeutic trials: Trial "2 cycles" and trial "9 cycles" (Fleming plan in one stage).
This will mean prospective multicentre studies, around a treatment with the lenalidomide-dexamethasone combination in patients suffering from POEMS syndrome either de novo, resistant or in relapse.
Both trials carried out in parallel are complementary regarding the eligibility criteria:
- Group 1: the "2-cycles" trial will be available to patients who can be treated by radiation or intensive treatment (75 % of cases occurring in front line); they will then undergo 2 cycles of the lenalidomide-dexamethasone combination before radiation or intensive treatment (Group 1).
- Group 2 : the "9-cycles" trial will be available to all other front-line patients (25 % of front-line patients) or patients in relapse or resistant, they will undergo 9 cycles of the lenalidomide-dexamethasone combination followed by maintenance therapy with lenalidomide alone for one year (Group 2).
Both these trials carried out within the same study will enable us to answer the question of potential efficacy of lenalidomide in POEMS syndrome and could enable us to draw up a new therapeutic standard.
Main objective:
Group 1: to evaluate the efficacy of the Len-Dex combination on the biological response after 2 cycles in patients with POEMS syndrome who can undergo radiation or intensive treatment.
Group 2: to evaluate the efficacy of the Len-Dex combination on the biological response in patients with POEMS syndrome who cannot be treated by radiation or intensive treatment.
- Conditions
- POEMS Syndrome
- Being tested
- Lenalidomide and dexamethasone
- Keywords
- POEMS, VEGF, Free light, lenalidomide, 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
2 cycles of the lenalidomide-dexamethasone (Len-Dex) combination before radiation or intensive treatment
Lenalidomide and dexamethasoneDrug
9 cycles of the Len-Dex combination
| Study group | Role | What they receive |
|---|---|---|
| Group 1 ("2-cycles" trial) | Experimental | The "2-cycles" trial will be available to patients who can be treated by radiation or intensive treatment (75 % of cases occurring in front line); they will then undergo 2 cycles of the lenalidomide-dexamethasone combination before radiation or intensive treatment (Group 1). Receives: Drug: Lenalidomide and dexamethasone |
| Group 2 ( "9 cylces" Trial) | Experimental | The "9-cycles" trial will be available to all other front-line patients (25 % of front-line patients) or patients in relapse or resistant, they will undergo 9 cycles of the lenalidomide-dexamethasone combination followed by maintenance therapy with lenalidomide alone for one year (Group 2). Receives: Drug: Lenalidomide and dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biological outcome
Decrease of monoclonal protein and serum VEGF level
Measured: Two months for group 1
Biological outcome
Decrease of monoclonal protein and serum VEGF level
Measured: 2, 4 or 6 month for group 2
Secondary outcomes (1)
Clinical response
Evaluation of the neurological (Overall Neuropathy Limitations Scale, Neuropsychological Impairment Scale and 10 m walking test) and other damages responses:
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionJun 2018
- Study completionJul 2018
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 University Hospital, LimogesThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France, Celgene Corporation
- Responsible party
- Sponsor
- Investigators
- Arnaud JACCARD, MD, Study chair, CHU Limoges
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01639898
- Sponsor's protocol ID
- I10 015
- Other IDs
- 2011-000635-83
- Acronym
- POEMS
- Status last verified
- Jul 2019
- First submitted
- 5 Jul 2012
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial With Lenalidomide-Dexamethasone Combination in the Treatment of POEMS Syndrome.
- ClinicalTrials.gov ID
- NCT01639898
- Acronym / sponsor ID
- POEMS / I10 015
- Conditions
- POEMS Syndrome
- Keywords
- POEMS, VEGF, Free light, lenalidomide, dexamethasone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Collaborators
- Ministry of Health, France, Celgene Corporation
- Study start
- Jul 2012 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 13 Jul 2012 (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.
POEMS syndrome is a rare form of B cell dyscrasia combining a proliferation usually of plasma cells, a polyneuropathy, osteocondensing bone lesions and multiple other clinical signs. Lenalidomide appears to be particularly efficient in this pathology.
The investigators propose a phase II multicentre protocol, based on the use of lenalidomide combined with dexamethasone in patients presenting a POEMS syndrome, either de novo or resistant or in relapse.
Patients who can be treated by local radiation or intensive treatment with stem cell support will undergo 2 cycles of the lenalidomide-dexamethasone (Len-Dex) combination before radiation or intensive treatment (Group 1), the other patients will undergo 9 cycles of the Len-Dex combination (Group 2).
A biological study is coupled with this clinical protocol in order to define the best biological markers predicting clinical responses, to better understand the POEMS pathophysiological mechanisms and to set up a bank of samples which can be used to study this rare pathology.
Detailed description
The investigators propose to simultaneously set up two Phase II therapeutic trials: Trial "2 cycles" and trial "9 cycles" (Fleming plan in one stage).
This will mean prospective multicentre studies, around a treatment with the lenalidomide-dexamethasone combination in patients suffering from POEMS syndrome either de novo, resistant or in relapse.
Both trials carried out in parallel are complementary regarding the eligibility criteria:
- Group 1: the "2-cycles" trial will be available to patients who can be treated by radiation or intensive treatment (75 % of cases occurring in front line); they will then undergo 2 cycles of the lenalidomide-dexamethasone combination before radiation or intensive treatment (Group 1).
- Group 2 : the "9-cycles" trial will be available to all other front-line patients (25 % of front-line patients) or patients in relapse or resistant, they will undergo 9 cycles of the lenalidomide-dexamethasone combination followed by maintenance therapy with lenalidomide alone for one year (Group 2).
Both these trials carried out within the same study will enable us to answer the question of potential efficacy of lenalidomide in POEMS syndrome and could enable us to draw up a new therapeutic standard.
Main objective:
Group 1: to evaluate the efficacy of the Len-Dex combination on the biological response after 2 cycles in patients with POEMS syndrome who can undergo radiation or intensive treatment.
Group 2: to evaluate the efficacy of the Len-Dex combination on the biological response in patients with POEMS syndrome who cannot be treated by radiation or intensive treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 ("2-cycles" trial) | Experimental | Drug: Lenalidomide and dexamethasoneThe "2-cycles" trial will be available to patients who can be treated by radiation or intensive treatment (75 % of cases occurring in front line); they will then undergo 2 cycles of the lenalidomide-dexamethasone combination before radiation or intensive treatment (Group 1). |
| Group 2 ( "9 cylces" Trial) | Experimental | Drug: Lenalidomide and dexamethasoneThe "9-cycles" trial will be available to all other front-line patients (25 % of front-line patients) or patients in relapse or resistant, they will undergo 9 cycles of the lenalidomide-dexamethasone combination followed by maintenance therapy with lenalidomide alone for one year (Group 2). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients suffering from POEMS syndrome (Mayo Clinic criteria)
- Patients with a localised disease who can be treated with radiation and those with a disseminated disease and who can be treated intensively will be included in Group 1, all other patients will be included in Group 2.
- Patients aged of 18 or more
- Patients who do not show uncontrolled thrombosis
- Patients who have been duly informed and who have signed a consent form.
Key exclusion criteria (14 listed)
- Women who are pregnant, or suspected to be pregnant or breastfeeding
- Pathology not linked with POEMS, contraindicating one of the studied drugs
- Patients suffering from a deficiency which does not allow them full understanding of the trial requirements and which could compromise proper consent from the patient and/or observance of the protocol and continuous participation in the trial.
- Prior history of malignancy other than POEMS syndrome or active other cancer or other serious illness.
- Any contraindication to Revlimid® or to one of its excipient.
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 dexamethasone2 cycles of the lenalidomide-dexamethasone (Len-Dex) combination before radiation or intensive treatment | Drug | Group 1 ("2-cycles" trial) |
| Lenalidomide and dexamethasone9 cycles of the Len-Dex combination | Drug | Group 2 ( "9 cylces" Trial) |
Primary outcome
Biological outcome
Time frame: Two months for group 1
Decrease of monoclonal protein and serum VEGF level
Biological outcome
Time frame: 2, 4 or 6 month for group 2
Decrease of monoclonal protein and serum VEGF level
1 secondary outcome
Clinical response
Time frame: 2 months
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 31 Aug 2026.
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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.
Arnaud JACCARD, MD study chair
CHU Limoges
11 sites 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 University Hospital, Limoges at 11 sites in France.
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 7 inclusion and 14 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 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. 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?
Biological outcome (time frame: Two months for group 1). The study lists 2 primary outcomes in all. 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 Aug 2026.