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POEMS Syndrome Treatment With Lenalidomide
Sponsor: University Hospital, Limoges
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.
Official title: Phase II Trial With Lenalidomide-Dexamethasone Combination in the Treatment of POEMS Syndrome.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
51
Start Date
2012-07
Completion Date
2018-07
Last Updated
2026-08-31
Healthy Volunteers
No
Conditions
Interventions
Lenalidomide and dexamethasone
2 cycles of the lenalidomide-dexamethasone (Len-Dex) combination before radiation or intensive treatment
Lenalidomide and dexamethasone
9 cycles of the Len-Dex combination
Locations (11)
CHU d'Angers
Angers, France
CHU de Caen
Caen, France
CHU de Lille
Lille, France
CHU de Limoges
Limoges, France
Hospices Civil de Lyon
Lyon, France
Centre Léon Bérard
Lyon, France
CHU de Nantes
Nantes, France
Hôpital Saint-Louis
Paris, France
Pitié Salpétrière
Paris, France
Hôpital Necker
Paris, France
CHU de Toulouse
Toulouse, France