POEMS Syndrome Treatment With Lenalidomide

• Status: Completed
• Trial end date: 2018-07-01
• Target enrollment: 0
• Participant gender: All

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.

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Limoges
• Collaborators: Celgene Corporation; Ministry of Health, France
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Lenalidomide; Thalidomide

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.