POEMS Syndrome Treatment With Lenalidomide
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial With Lenalidomide-Dexamethasone Combination in the Treatment of POEMS Syndrome.|
- Biological outcome [ Time Frame: Two months for group 1 ] [ Designated as safety issue: Yes ]Decrease of monoclonal protein and serum VEGF level
- Biological outcome [ Time Frame: 2, 4 or 6 month for group 2 ] [ Designated as safety issue: Yes ]Decrease of monoclonal protein and serum VEGF level
- Clinical response [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]Evaluation of the neurological (Overall Neuropathy Limitations Scale, Neuropsychological Impairment Scale and 10 m walking test) and other damages responses:
|Study Start Date:||July 2012|
|Estimated Study Completion Date:||July 2017|
|Estimated Primary Completion Date:||July 2016 (Final data collection date for primary outcome measure)|
Experimental: Group 1 ("2-cycles" trial)
The "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).
Drug: Lenalidomide and dexamethasone
2 cycles of the lenalidomide-dexamethasone (Len-Dex) combination before radiation or intensive treatment
Experimental: Group 2 ( "9 cylces" Trial)
The "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).
Drug: Lenalidomide and dexamethasone
9 cycles of the Len-Dex combination
The investigators propose to simultaneously set up two Phase II therapeutic trials: Trial "2 cycles" and trial "9 cycles" (Fleming plan in one stage).
This will mean prospective multicentre studies, around a treatment with the lenalidomide-dexamethasone combination in patients suffering from POEMS syndrome either de novo, resistant or in relapse.
Both trials carried out in parallel are complementary regarding the eligibility criteria:
- Group 1: the "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 : the "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).
Both these trials carried out within the same study will enable us to answer the question of potential efficacy of lenalidomide in POEMS syndrome and could enable us to draw up a new therapeutic standard.
Group 1: to evaluate the efficacy of the Len-Dex combination on the biological response after 2 cycles in patients with POEMS syndrome who can undergo radiation or intensive treatment.
Group 2: to evaluate the efficacy of the Len-Dex combination on the biological response in patients with POEMS syndrome who cannot be treated by radiation or intensive treatment.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01639898
|Contact: Arnaud JACCARD, MDfirstname.lastname@example.org|
|Contact: Julie ABRAHAM, MDemail@example.com|
|Angers, France, 49933|
|Contact: Ifrah NORBERT, MD 0241354472|
|Principal Investigator: Ifrah NORBERT, MD|
|Sub-Investigator: Mamoun DIB, MD|
|Sub-Investigator: Martine GARDEMBAS-PAIN, MD|
|CHU de Caen||Recruiting|
|Caen, France, 14000|
|Contact: Margaret MACRO, MD 02 31 27 25 39 firstname.lastname@example.org|
|Principal Investigator: Margaret MACRO, MD|
|Sub-Investigator: Khaled BENABED, MD|
|Sub-Investigator: Sylvain CHANTEPIE, MD|
|Sub-Investigator: Xavier TROUSSARD, MD|
|Sub-Investigator: Stéphane CHEZE, MD|
|Sub-Investigator: Anne-Claire GAC-BESNARD, MD|
|Sub-Investigator: Hyacinthe Atchroué JOHNSON-ANSAH, MD|
|Sub-Investigator: Oumédaly REMAN, MD|
|CHU de Lille||Recruiting|
|Lille, France, 59037|
|Contact: Xavier LELEU, MD 0320444290|
|Principal Investigator: Xavier LELEU, MD|
|Sub-Investigator: Thierry FACON, MD|
|CHU de Limoges||Recruiting|
|Limoges, France, 87042|
|Contact: Arnaud JACCARD, MD 0555056651 email@example.com|
|Contact: Julie ABRAHAM, MD 0555056651 firstname.lastname@example.org|
|Principal Investigator: Arnaud JACCARD, MD|
|Sub-Investigator: Michel COGNE, MD|
|Sub-Investigator: Dominique BORDESSOULE, MD|
|Sub-Investigator: Stéphane MOREAU, MD|
|Sub-Investigator: Liliane REMINIERAS, MD|
|Sub-Investigator: Marie-Pierre GOURIN, MD|
|Sub-Investigator: Mohamed TOUATI, MD|
|Sub-Investigator: Stéphane GIRAULT, MD|
|Sub-Investigator: Pascal TURLURE, MD|
|Hospices Civil de Lyon||Recruiting|
|Lyon, France, 69000|
|Contact: lionel KARLIN, MD 0478864309 email@example.com|
|Sub-Investigator: Lionel Karlin, MD|
|Centre Léon Bérard||Not yet recruiting|
|Lyon, France, 69373|
|Contact: GHESQUIERES Hervé, MD 0478782684 firstname.lastname@example.org|
|Principal Investigator: Hervé GHESQUIERES, MD|
|CHU de Nantes||Recruiting|
|Nantes, France, 44093|
|Contact: Philippe MOREAU, MD 0240083271 email@example.com|
|Principal Investigator: Philippe MOREAU, MD|
|Paris, France, 75013|
|Contact: Véronique LEBLOND, MD 0142162824|
|Principal Investigator: Véronique LEBLOND, MD|
|Sub-Investigator: Sylvain CHOQUET, MD|
|Paris, France, 75743|
|Contact: Olivier HERMINE, MD 0144495282|
|Contact: Felipe SUAREZ, MD 0144495286 firstname.lastname@example.org|
|Principal Investigator: Olivier HERMINE, MD|
|Sub-Investigator: Felipe SUAREZ, MD|
|Sub-Investigator: Flore SICRE de FONTBRUNE, MD|
|Sub-Investigator: Ambroise MARCAIS, MD|
|Sub-Investigator: Laurent FRENZEL, MD|
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|Paris, France, 75010|
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|Principal Investigator: Jean-Paul FERMAND, MD|
|CHU de Toulouse||Recruiting|
|Toulouse, France, 31059|
|Contact: Michel Attal, MD 0561777784 firstname.lastname@example.org|
|Principal Investigator: Michel ATTAL, MD|
|Study Chair:||Arnaud JACCARD, MD||CHU Limoges|