Ixazomib Citrate, Lenalidomide, and Dexamethasone in Treating Patients With POEMS Syndrome (NCT02921893) | Clinical Trial Compass
CompletedEarly Phase 1
Ixazomib Citrate, Lenalidomide, and Dexamethasone in Treating Patients With POEMS Syndrome
United States21 participantsStarted 2016-10-31
Plain-language summary
This phase II trial studies how well ixazomib citrate, lenalidomide, and dexamethasone work in treating patients with polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome. Ixazomib citrate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as lenalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Anti-inflammatory drugs, such as dexamethasone lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Giving ixazomib citrate, lenalidomide, and dexamethasone may work better in treating patients with POEMS syndrome.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* POEMS syndrome requiring therapy, previously treated or untreated
* Plasma vascular endothelial growth factor (VEGF) \> 2 x upper limit of normal (ULN)
* Presence of a plasma cell clone (any of the following):
* Monoclonal protein in the serum or urine
* Measurable light chains by free light chain assay
* Measurable plasmacytoma
* Monoclonal plasma cells in bone marrow
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, 2, or 3
* Absolute neutrophil count (ANC) \>= 1000/uL obtained =\< 14 days prior to registration
* Platelet count (PLT) \>= 75,000/uL obtained =\< 14 days prior to registration
* Total bilirubin =\< 2.0 mg/dL unless due to known Gilbert's disease obtained =\< 14 days prior to registration
* NOTE: If total bilirubin is \> 2 mg/dL, a direct bilirubin should be performed and must be \< 1.5 mg/dL for Gilbert's to be diagnosed
* Alanine aminotransferase (ALT/serum glutamic pyruvic transaminase \[SGPT\]) and aspartate aminotransferase (AST, serum glutamic oxaloacetic transaminase \[SGOT\]) =\< 3 x upper limit of normal (ULN) obtained =\< 14 days prior to registration
* Creatinine clearance \>= 30 mL/min/1.73 m\^2 (as determined by Cockcroft-Gault equation) obtained =\< 14 days prior to registration
* Negative serum pregnancy test done =\< 7 days prior to registration, for women of childbearing potential only
* NOTE: Females of reproductive potential must adhere to the scheduled pregnancy testing as required…
What they're measuring
1
Rate of normalization of VEGF defined as VEGF value decreasing to below upper limit of normal (86 pg/mL)