A Phase 2 interventional study of Lenalidomide and dexamethasone in POEMS Syndrome, sponsored by Istituto Clinico Humanitas. Status unknown at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-09-02.
Sponsored by Istituto Clinico Humanitas · Phase 2, Interventional, and Treatment
Lenalidomide is a immunomodulatory drug derived from thalidomide, without neurotoxicity. Lenalidomide blocks the increased secretion of interleukin-6, tumor necrosis factor alpha and vascular endothelial growth factor (VEGF). The association with dexamethasone increased Lenalidomide response rate.
More recently the efficacy of Lenalidomide has been reported in a patient with POEMS (POEMS:polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes) syndrome with improvement of clinical condition and reduction of vascular endothelial growth factor (VEGF) and interleukin-6 (IL-6) level.
Istituto Clinico Humanitas is the lead sponsor of 279 studies on the registry; 71 are open to participants now.
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RD regimen: Lenalidomide 25 mg/die for 21 days every month for 6 cycles, with once-weekly dexamethasone (40 mg).
Drug: Lenalidomide and dexamethasone
Drug pages: Lenalidomide · Dexamethasone
RD regimen: Lenalidomide 25 mg/die for 21 days every month for 6 cycles, with once-weekly dexamethasone (40 mg).
Evaluation of clinical efficacy of Lenalidomide for 21 days every month for 6 cycles, with once-weekly dexamethasone (40 mg)) in patients with POEMS syndrome after 6 cycles.
Time frame: one year
Evaluation of the safety and the activity.
Time frame: one year
The record gives a start of Jul 2009, a primary completion of Dec 2009 and a completion of Jul 2011. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Sep 2010. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Lenalidomide · Dexamethasone
POEMS Syndrome