The purpose of this prospective study is to determine the efficacy and safety of lenalidomide plus dexamethasone in patients with newly diagnosed POEMS syndrome.
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 rate according to international myeloma working group (IMWG) response criteria for amyloidosis and neurological response rate defined by overall neuropathy limitation scale (ONLS) score. This study expects to enroll approximately 41 subjects.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
41
12 cycles of lenalidomide and dexamethasone, each cycle lasts 28 days. For patients with Ccr equal to or higher than 30ml/min, oral lenalidomide 10mg once daily for days 1-21 out of a 28 cycle. For patients with Ccr lower than 30ml/min, oral lenalidomide 10mg once every other day for days 1-21 out of a 28 cycle. All the patients take Dexamethasone orally 40mg once weekly for day 1,8,15,22 out of a 28 cycle.
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Hematological response rate
Time frame: last day of the LDx treatment regimen (up to 9 months)
Neurological response rate defined by ONLS score
Time frame: last day of the LDx treatment regimen (up to 9 months)
response rate of critical organs
Time frame: every month during the first 3 months calculated from the day study started, then every 3 months in the next 9 months
Response rate of serum vascular endothelial growth factor (VEGF) level
Time frame: every month during the first 3 months calculated from the day study started, then every 3 months in the next 9 months
Time to initial neurological response
Time frame: every month during the first 3 months calculated from the day study started, then every 3 months in the next 9 months
Overall survival
Time frame: From date of first diagnosis until the date of death from any cause, otherwise patients will be censored in June, 2018 (up to 5 years)
Relapse free survival
Time frame: From date of first diagnosis until the date of first documented relapse or date of death from any cause, whichever came first, otherwise patients will be censored in June, 2018 (up to 5 years)
adverse events
Time frame: throughout the treatment and until 30 days after the administration of the last dose of a study drug
time to the best neurological response
Time frame: every month during the first 3 months calculated from the day study started, then every 3 months in the next 9 months
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