Pomalidomide, Ixazomib Citrate, and Dexamethasone in Treating Patients With Previously Treated Mu… (NCT02547662) | Clinical Trial Compass
CompletedPhase 2
Pomalidomide, Ixazomib Citrate, and Dexamethasone in Treating Patients With Previously Treated Multiple Myeloma or Plasma Cell Leukemia
United States17 participantsStarted 2015-12-24
Plain-language summary
This phase II trial studies how well pomalidomide, ixazomib citrate, and dexamethasone work in treating patients with previously treated multiple myeloma or plasma cell leukemia. Biological therapies, such as pomalidomide and dexamethasone, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Ixazomib citrate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving pomalidomide, ixazomib citrate, and dexamethasone together may be more effective in treating multiple myeloma.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Previously treated myeloma, currently with extramedullary disease (defined as plasmacytoma outside bone marrow that is not contiguous with a bone lesion) with at least one lesion that has a single diameter of \>= 2 cm or plasma cell leukemia (defined as circulating plasma cells exceeding 5% of peripheral blood leukocytes or 0.5 X 10\^9/L or 200 cells/150000 events by flow cytometry)
* Calculated creatinine clearance (using Cockcroft-Gault equation) \>= 30 mL/min
* Absolute neutrophil count (ANC) \>= 1000/mm\^3
* Platelet count \>= 50,000/mm\^3
* Hemoglobin \>= 8.0 g/dL
* Patients with measurable disease defined as at least one of the following:
* For patients with extramedullary disease (EMD) measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) or the CT portion of the positron emission tomography (PET)/CT: must have at least one lesion that has a single diameter of \>= 2 cm; skin lesions can be used if the area is \>= 2 cm in at least one diameter and measured with a ruler
* Plasma cell count \>= 0.5 X 10\^9/L or 5 percent of the peripheral blood white cells
* Plasma cell count if determined by flow cytometry, \>= 200/150,000 events
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
* Provide informed written consent
* Negative pregnancy test done =\< 7 days prior to registration, for women of childbearing potential only
* All study participants must be registered into the mandatory pomali…