Carfilzomib, Lenalidomide, and Dexamethasone Before and After Stem Cell Transplant in Treating Pa… (NCT01816971) | Clinical Trial Compass
CompletedPhase 2
Carfilzomib, Lenalidomide, and Dexamethasone Before and After Stem Cell Transplant in Treating Patients With Newly Diagnosed Multiple Myeloma
United States, Canada76 participantsStarted 2013-01
Plain-language summary
This phase II trial studies how well carfilzomib, lenalidomide, and dexamethasone before and after stem cell transplant works in treating patients with newly diagnosed multiple myeloma. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from diving. Giving carfilzomib, lenalidomide, and dexamethasone before and after stem cell transplant may kill more cancer cells
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Newly diagnosed, myeloma requiring systemic chemotherapy as per International Myeloma Working Group (IMWG) uniform criteria:
* Prior treatment of hypercalcemia or spinal cord compression or active and/or aggressively progressing myeloma with corticosteroids or lenalidomide or bortezomib-based regimens does not disqualify the patient (the treatment dose should not exceed the equivalent of 160 mg of dexamethasone in a 4 week period or not more than 1 cycle)
* Bisphosphonates are permitted
* Suitable and interested to proceed to ASCT
* Measurable disease, prior to initial treatment as indicated by one or more of the following:
* Serum monoclonal (M)-protein \>= 0.5 g/dL
* Urine M-protein \>= 200 mg/24 hours
* If serum protein electrophoresis is felt to be unreliable for routine M-protein measurement, then quantitative immunoglobulin levels are acceptable
* Life expectancy of more than 3 months
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Bilirubin \< 1.5 times the upper limit of normal (ULN)
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 2.5 times ULN
* Absolute neutrophil count (ANC) \>= 1.0 x 10\^9/L
* Hemoglobin \>= 8 g/dL
* Platelet count \>= 75 x 10\^9/L; subjects may receive red blood cell (RBC) transfusions or platelet transfusions, if clinically indicated in accordance with institutional guidelines; however, screening platelet count should be independent of platelet transfusions for at l…