Can a Two-Drug combo tame a rare nerve and blood disorder?
NCT ID NCT01639898
First seen Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time
Summary
This phase II trial tests whether the combination of lenalidomide and dexamethasone can help people with POEMS syndrome, a rare blood disorder that damages nerves and causes other symptoms. Participants receive the drug combo either before local radiation or intensive treatment, or as the main therapy for nine cycles. The study also collects blood samples to look for markers that predict response and to better understand the disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- lenalidomide combined with dexamethasone
- What this could lead to
- If it works, this drug combination could offer a new treatment option for POEMS syndrome, a rare and serious blood disorder, potentially improving nerve function and other symptoms.
- What could go wrong
- This is a phase II trial with a small number of participants, so the results are not definitive. The treatment may not work for everyone, and lenalidomide can have side effects like blood clots, low blood counts, and infections.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
51 people
The number who actually took part.
- Started
-
Jul 2012
- Finished
-
Jul 2018
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Poems syndrome are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
CHU d'Angers
Angers, 49933, France
-
CHU de Caen
Caen, 14000, France
-
CHU de Lille
Lille, 59037, France
-
CHU de Limoges
Limoges, 87042, France
-
CHU de Nantes
Nantes, 44093, France
-
CHU de Toulouse
Toulouse, 31059, France
-
Centre Léon Bérard
Lyon, 69373, France
-
Hospices Civil de Lyon
Lyon, 69000, France
-
Hôpital Necker
Paris, 75743, France
-
Hôpital Saint-Louis
Paris, 75010, France
-
Pitié Salpétrière
Paris, 75013, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.