POEMS Syndrome Treatment With Lenalidomide

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University Hospital, Limoges
Sponsor:
Collaborators:
Ministry of Health, France
Celgene Corporation
Information provided by (Responsible Party):
University Hospital, Limoges
ClinicalTrials.gov Identifier:
NCT01639898
First received: July 5, 2012
Last updated: May 9, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
POEMS Syndrome
Drug: Lenalidomide and dexamethasone
Phase 2

Study Type: Interventional
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.

Resource links provided by NLM:


Further study details as provided by University Hospital, Limoges:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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:


Estimated Enrollment: 66
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)
Arms Assigned Interventions
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

Detailed Description:

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.

Main objective:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01639898

Contacts
Contact: Arnaud JACCARD, MD 0555056651 arnaud.jaccard@chu-limoges.fr
Contact: Julie ABRAHAM, MD 0555056651 julie.abraham@chu-limoges.fr

Locations
France
CHU d'Angers Recruiting
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    macro-m@chu-caen.fr   
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    arnaurd.jaccard@chu-limoges.fr   
Contact: Julie ABRAHAM, MD    0555056651    julie.abraham@chu-limoges.fr   
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         
Centre Léon Bérard Not yet recruiting
Lyon, France, 69373
Contact: GHESQUIERES Hervé, MD    0478782684    ghesquie@lyon.fnclcc.fr   
Principal Investigator: Hervé GHESQUIERES, MD         
Hospices Civil de Lyon Recruiting
Lyon, France, 69000
Contact: lionel KARLIN, MD    0478864309    lionel.karlin@chu-lyon.fr   
Sub-Investigator: Lionel Karlin, MD         
CHU de Nantes Recruiting
Nantes, France, 44093
Contact: Philippe MOREAU, MD    0240083271    philippe.moreau@chu-nantes.fr   
Principal Investigator: Philippe MOREAU, MD         
Hôpital Saint-Louis Recruiting
Paris, France, 75010
Contact: Jean-Paul FERMAND, MD    0142499692    jpfermand@yahoo.fr   
Principal Investigator: Jean-Paul FERMAND, MD         
Hôpital Necker Recruiting
Paris, France, 75743
Contact: Olivier HERMINE, MD    0144495282      
Contact: Felipe SUAREZ, MD    0144495286    felipe.suarez@nck.aphp.fr   
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         
Sub-Investigator: Richard DELARUE, MD         
Pitié Salpétrière Recruiting
Paris, France, 75013
Contact: Véronique LEBLOND, MD    0142162824      
Principal Investigator: Véronique LEBLOND, MD         
Sub-Investigator: Sylvain CHOQUET, MD         
CHU de Toulouse Recruiting
Toulouse, France, 31059
Contact: Michel Attal, MD    0561777784    attal.m@chu-toulouse.fr   
Principal Investigator: Michel ATTAL, MD         
Sponsors and Collaborators
University Hospital, Limoges
Ministry of Health, France
Celgene Corporation
Investigators
Study Chair: Arnaud JACCARD, MD CHU Limoges
  More Information

No publications provided

Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT01639898     History of Changes
Other Study ID Numbers: I10 015
Study First Received: July 5, 2012
Last Updated: May 9, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by University Hospital, Limoges:
POEMS
VEGF
Free light
lenalidomide
dexamethasone

Additional relevant MeSH terms:
POEMS Syndrome
Polyneuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Abnormalities, Multiple
Congenital Abnormalities
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Lenalidomide
Thalidomide
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on July 20, 2014