POEMS Syndrome Treatment With Lenalidomide
POEMS
Phase II Trial With Lenalidomide-Dexamethasone Combination in the Treatment of POEMS Syndrome.
1 other identifier
interventional
51
1 country
11
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jul 2012
Longer than P75 for phase_2
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 5, 2012
CompletedFirst Posted
Study publicly available on registry
July 13, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2018
CompletedJuly 5, 2019
July 1, 2019
5.9 years
July 5, 2012
July 2, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Biological outcome
Decrease of monoclonal protein and serum VEGF level
Two months for group 1
Biological outcome
Decrease of monoclonal protein and serum VEGF level
2, 4 or 6 month for group 2
Secondary Outcomes (1)
Clinical response
2 months
Study Arms (2)
Group 1 ("2-cycles" trial)
EXPERIMENTALThe "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).
Group 2 ( "9 cylces" Trial)
EXPERIMENTALThe "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).
Interventions
2 cycles of the lenalidomide-dexamethasone (Len-Dex) combination before radiation or intensive treatment
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Limogeslead
- Ministry of Health, Francecollaborator
- Celgene Corporationcollaborator
Study Sites (11)
CHU d'Angers
Angers, 49933, France
CHU de Caen
Caen, 14000, France
CHU de Lille
Lille, 59037, France
CHU de Limoges
Limoges, 87042, France
Hospices Civil de Lyon
Lyon, 69000, France
Centre Léon Bérard
Lyon, 69373, France
CHU de Nantes
Nantes, 44093, France
Hôpital Saint-Louis
Paris, 75010, France
Pitié Salpétrière
Paris, 75013, France
Hôpital Necker
Paris, 75743, France
CHU de Toulouse
Toulouse, 31059, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Arnaud JACCARD, MD
CHU Limoges
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 5, 2012
First Posted
July 13, 2012
Study Start
July 1, 2012
Primary Completion
June 1, 2018
Study Completion
July 1, 2018
Last Updated
July 5, 2019
Record last verified: 2019-07