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COMPLETED
NCT01639898
PHASE2

POEMS Syndrome Treatment With Lenalidomide

Sponsor: University Hospital, Limoges

View on ClinicalTrials.gov

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

DRUG

Lenalidomide and dexamethasone

2 cycles of the lenalidomide-dexamethasone (Len-Dex) combination before radiation or intensive treatment

DRUG

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