POEMS Syndrome Treatment With Lenalidomide

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01639898
• Date of registration: 05/07/2012
• Prospective Registration: No
• 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
• 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)

Ministry of Health, France

Celgene Corporation