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POEMS Syndrome Treatment With Lenalidomide

NCT01639898 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2019-07-05

No results posted yet for this study

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.

Conditions

  • POEMS Syndrome

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

Sponsors & Collaborators

  • Ministry of Health, France

    collaborator OTHER_GOV

  • Celgene Corporation

    collaborator INDUSTRY

  • University Hospital, Limoges

    lead OTHER

Principal Investigators

  • Arnaud JACCARD, MD · CHU Limoges

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2018-06-30
Completion
2018-07-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01639898 on ClinicalTrials.gov