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POEMS Syndrome Treatment With Lenalidomide (POEMS)

Primary Purpose

POEMS Syndrome

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Lenalidomide and dexamethasone
Lenalidomide and dexamethasone
Sponsored by
University Hospital, Limoges
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for POEMS Syndrome focused on measuring POEMS, VEGF, Free light, lenalidomide, dexamethasone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHU d'Angers
  • CHU de Caen
  • CHU de Lille
  • CHU de Limoges
  • Hospices Civil de Lyon
  • Centre Léon Bérard
  • CHU de Nantes
  • Hôpital Saint-Louis
  • Pitié Salpétrière
  • Hôpital Necker
  • CHU de Toulouse

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group 1 ("2-cycles" trial)

Group 2 ( "9 cylces" Trial)

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

Biological outcome
Decrease of monoclonal protein and serum VEGF level
Biological outcome
Decrease of monoclonal protein and serum VEGF level

Secondary Outcome Measures

Clinical response
Evaluation of the neurological (Overall Neuropathy Limitations Scale, Neuropsychological Impairment Scale and 10 m walking test) and other damages responses:

Full Information

First Posted
July 5, 2012
Last Updated
July 2, 2019
Sponsor
University Hospital, Limoges
Collaborators
Ministry of Health, France, Celgene Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01639898
Brief Title
POEMS Syndrome Treatment With Lenalidomide
Acronym
POEMS
Official Title
Phase II Trial With Lenalidomide-Dexamethasone Combination in the Treatment of POEMS Syndrome.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
July 2012 (Actual)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
July 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Limoges
Collaborators
Ministry of Health, France, Celgene Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
POEMS Syndrome
Keywords
POEMS, VEGF, Free light, lenalidomide, dexamethasone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 ("2-cycles" trial)
Arm Type
Experimental
Arm Description
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).
Arm Title
Group 2 ( "9 cylces" Trial)
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Lenalidomide and dexamethasone
Intervention Description
2 cycles of the lenalidomide-dexamethasone (Len-Dex) combination before radiation or intensive treatment
Intervention Type
Drug
Intervention Name(s)
Lenalidomide and dexamethasone
Intervention Description
9 cycles of the Len-Dex combination
Primary Outcome Measure Information:
Title
Biological outcome
Description
Decrease of monoclonal protein and serum VEGF level
Time Frame
Two months for group 1
Title
Biological outcome
Description
Decrease of monoclonal protein and serum VEGF level
Time Frame
2, 4 or 6 month for group 2
Secondary Outcome Measure Information:
Title
Clinical response
Description
Evaluation of the neurological (Overall Neuropathy Limitations Scale, Neuropsychological Impairment Scale and 10 m walking test) and other damages responses:
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arnaud JACCARD, MD
Organizational Affiliation
CHU Limoges
Official's Role
Study Chair
Facility Information:
Facility Name
CHU d'Angers
City
Angers
ZIP/Postal Code
49933
Country
France
Facility Name
CHU de Caen
City
Caen
ZIP/Postal Code
14000
Country
France
Facility Name
CHU de Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
CHU de Limoges
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Hospices Civil de Lyon
City
Lyon
ZIP/Postal Code
69000
Country
France
Facility Name
Centre Léon Bérard
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
CHU de Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Hôpital Saint-Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Pitié Salpétrière
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Hôpital Necker
City
Paris
ZIP/Postal Code
75743
Country
France
Facility Name
CHU de Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France

12. IPD Sharing Statement

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POEMS Syndrome Treatment With Lenalidomide

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