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POEMS Syndrome Treatment With Lenalidomide (POEMS)

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ClinicalTrials.gov Identifier: NCT01639898
Recruitment Status : Completed
First Posted : July 13, 2012
Last Update Posted : July 5, 2019
Sponsor:
Collaborators:
Ministry of Health, France
Celgene Corporation
Information provided by (Responsible Party):
University Hospital, Limoges

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.


Condition or disease Intervention/treatment Phase
POEMS Syndrome Drug: Lenalidomide and dexamethasone Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial With Lenalidomide-Dexamethasone Combination in the Treatment of POEMS Syndrome.
Actual Study Start Date : July 2012
Actual Primary Completion Date : June 2018
Actual Study Completion Date : July 2018


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Biological outcome [ Time Frame: Two months for group 1 ]
    Decrease of monoclonal protein and serum VEGF level

  2. Biological outcome [ Time Frame: 2, 4 or 6 month for group 2 ]
    Decrease of monoclonal protein and serum VEGF level


Secondary Outcome Measures :
  1. Clinical response [ Time Frame: 2 months ]
    Evaluation of the neurological (Overall Neuropathy Limitations Scale, Neuropsychological Impairment Scale and 10 m walking test) and other damages responses:



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01639898


Locations
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France
CHU d'Angers
Angers, France, 49933
CHU de Caen
Caen, France, 14000
CHU de Lille
Lille, France, 59037
CHU de Limoges
Limoges, France, 87042
Hospices Civil de Lyon
Lyon, France, 69000
Centre Léon Bérard
Lyon, France, 69373
CHU de Nantes
Nantes, France, 44093
Hôpital Saint-Louis
Paris, France, 75010
Pitié Salpétrière
Paris, France, 75013
Hôpital Necker
Paris, France, 75743
CHU de Toulouse
Toulouse, France, 31059
Sponsors and Collaborators
University Hospital, Limoges
Ministry of Health, France
Celgene Corporation
Investigators
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Study Chair: Arnaud JACCARD, MD CHU Limoges
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Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT01639898    
Other Study ID Numbers: I10 015
First Posted: July 13, 2012    Key Record Dates
Last Update Posted: July 5, 2019
Last Verified: July 2019
Keywords provided by University Hospital, Limoges:
POEMS
VEGF
Free light
lenalidomide
dexamethasone
Additional relevant MeSH terms:
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POEMS Syndrome
Syndrome
Disease
Pathologic Processes
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
Dexamethasone acetate
Lenalidomide
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents