Status:
COMPLETED
Study to Evaluate Lenalidomide Plus Dexamethasone in Patients With Newly Diagnosed POEMS Syndrome
Lead Sponsor:
Peking Union Medical College Hospital
Collaborating Sponsors:
Celgene Corporation
Conditions:
POEMS Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this prospective study is to determine the efficacy and safety of lenalidomide plus dexamethasone in patients with newly diagnosed POEMS syndrome.
Detailed Description
The investigators propose to use the adverse effects as well as the need for dose reduction as a criterion to judge tolerability of treatment. The primary endpoint would be hematological response rat...
Eligibility Criteria
Inclusion
- Patients must understand and voluntarily sign an informed consent form.
- Older than 18 years old at the time of signing consent.
- Meet the diagnostic criteria of POEM syndrome.
- Must be cytotoxic treatment naive. However, previous or existing corticosteroid (prednisone or dexamethasone) or intravenous immunoglobin (IVIG) therapy is allowed.
- Women of childbearing potential must understand that the study medication could have a potential teratogenic risk. They should undergo complete contraception during the study period.
- Male subjects must agree to use condoms throughout study drug therapy.
Exclusion
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
- Pregnant or lactating females.
- Any of the following laboratory abnormalities:
- Absolute neutrophil count(ANC) of\<1.0×10E9 cell/L. Platelet count\<50×10E9 cell/L. Renal failure requiring dialysis. Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3 times of the normal upper limit.
- Prior history of malignancies, but not including basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, and T1a or T1b prostate cancer.
- Known hypersensitivity or prior history of uncontrollable side effects to dexamethasone therapy.
- Prior use of cytotoxic drugs.
- Subjects who are unable or unwilling to undergo antithrombotic therapy.
Key Trial Info
Start Date :
March 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2017
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT01816620
Start Date
March 1 2014
End Date
April 1 2017
Last Update
April 25 2017
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100005