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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT01639898
Date of registration: 05/07/2012
Prospective Registration: Yes
Primary sponsor: University Hospital, Limoges
Public title: POEMS Syndrome Treatment With Lenalidomide POEMS
Scientific title: Phase II Trial With Lenalidomide-Dexamethasone Combination in the Treatment of POEMS Syndrome.
Date of first enrolment: July 2012
Target sample size: 51
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT01639898
Study type:  Interventional
Study design:  Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 2
Countries of recruitment
France
Contacts
Name:     Arnaud JACCARD, MD
Address: 
Telephone:
Email:
Affiliation:  CHU Limoges
Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
POEMS Syndrome
Intervention(s)
Drug: Lenalidomide and dexamethasone
Primary Outcome(s)
Biological outcome [Time Frame: 2, 4 or 6 month for group 2]
Biological outcome [Time Frame: Two months for group 1]
Secondary Outcome(s)
Clinical response [Time Frame: 2 months]
Secondary ID(s)
I10 015
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Celgene Corporation
Ministry of Health, France
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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