A Phase 2 interventional study of Lenalidomide, Dexamethasone in POEMS Syndrome, sponsored by Peking Union Medical College Hospital. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-04-25.
Sponsored by Peking Union Medical College Hospital · Phase 2, Interventional, and Treatment
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.
9,217 studies on the registry are indexed under Syndrome; 1,031 are open to participants now.
This study's enrollment of 41 is below the median of 50 across 6,515 interventional studies indexed under Syndrome.
Browse Syndrome studies →Peking Union Medical College Hospital is the lead sponsor of 1,115 studies on the registry; 463 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Lenalidomide 10mg qd d1-21 \& dexamethasone 40mg qw d1,8,15,22
Drug: Lenalidomide, Dexamethasone
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.
Also known as: Revlimid
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
This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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POEMS Syndrome
Peking Union Medical College Hospital