POEMS Syndrome Treatment With Lenalidomide (POEMS)
POEMS Syndrome
About this trial
This is an interventional treatment trial for POEMS Syndrome focused on measuring POEMS, VEGF, Free light, lenalidomide, dexamethasone
Eligibility Criteria
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.
Sites / Locations
- CHU d'Angers
- CHU de Caen
- CHU de Lille
- CHU de Limoges
- Hospices Civil de Lyon
- Centre Léon Bérard
- CHU de Nantes
- Hôpital Saint-Louis
- Pitié Salpétrière
- Hôpital Necker
- CHU de Toulouse
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Group 1 ("2-cycles" trial)
Group 2 ( "9 cylces" Trial)
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).
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).