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Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.","id":"BG002","title":"Arm 3: 60 mg Leflunomide"},{"description":"Total of all reporting groups","id":"BG003","title":"Total"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","lowerLimit":"48","upperLimit":"72","value":"50"},{"groupId":"BG001","lowerLimit":"60","upperLimit":"67","value":"62"},{"groupId":"BG002","lowerLimit":"64","upperLimit":"85","value":"71"},{"groupId":"BG003","lowerLimit":"48","upperLimit":"85","value":"68"}]}]}],"dispersionType":"FULL_RANGE","paramType":"MEDIAN","title":"Age, Continuous","unitOfMeasure":"years"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"4"},{"groupId":"BG003","value":"6"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"6"}],"title":"Male"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Sex: Female, Male","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"2"}],"title":"Asian"},{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"4"}],"title":"Black"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"1"}],"title":"Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"4"},{"groupId":"BG003","value":"5"}],"title":"White, non-Hispanic"}],"title":"race/ethnicity"}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Race/Ethnicity, Customized","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"6"},{"groupId":"BG003","value":"12"}]}],"title":"United States"}],"paramType":"NUMBER","title":"Region of Enrollment","unitOfMeasure":"participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"3"}],"title":"Stage I"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"3"}],"title":"Stage II"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"3"}],"title":"Stage III"},{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"3"}],"title":"Unknown/missing"}]}],"description":"The International Staging System (ISS) consists of the following stages:\n\nStage I - serum beta-2 microglobulin less than 3.5 mg/L AND serum albumin greater than or equal to 3.5 g/dL ::\n\nStage II - neither stage I nor III ::\n\nstage III - serum beta-2 microglobulin greater than or equal to 5.5 mg/L :: Higher grade predicts worse outcome.\n\nJ Clin Oncol 23:3412-3420","paramType":"COUNT_OF_PARTICIPANTS","title":"ISS staging at diagnosis","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"4"},{"groupId":"BG003","value":"10"}],"title":"Yes"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"2"}],"title":"No"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Prior autologous transplant","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"4"}],"title":"Yes"},{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"5"},{"groupId":"BG003","value":"8"}],"title":"No"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Prior radiation","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"6"},{"groupId":"BG003","value":"11"}],"title":"Positive"},{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"1"}],"title":"Negative"}]}],"description":"Serum protein electrophoresis refers to the separation of different types of proteins, according to the differences in the surface charge of serum proteins. Immunoglobulin (Ig) exhibits tetrapeptide chain structure, which can be divided into five categories: IgA, IgM, IgD, IgE, or IgG. Serum Ig can be used in diagnosis of MM. Immunofixation electrophoresis involves the dissociation of electrophoresis and the high specificity (antigen-antibody reaction) and high sensitivity of monoclonal immunoglobulin to detect monoclonal components in serum. J Coll Physicians Surg Pak 2021; 31(07):864-867","paramType":"COUNT_OF_PARTICIPANTS","title":"Serum electrophoresis and immunofixation","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"3"},{"groupId":"BG003","value":"5"}],"title":"IgG kappa"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"3"}],"title":"IgG lambda"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}],"title":"IgA lambda"},{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"2"}],"title":"Serum unknown"},{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"2"}],"title":"IgA kappa"}]}],"description":"Serum protein electrophoresis refers to the separation of different types of proteins, according to the differences in the surface charge of serum proteins. Immunoglobulin (Ig) exhibits tetrapeptide chain structure, which can be divided into five categories: IgA, IgM, IgD, IgE, or IgG. Serum Ig can be used in diagnosis of MM. Immunofixation electrophoresis involves the dissociation of electrophoresis and the high specificity (antigen-antibody reaction) and high sensitivity of monoclonal immunoglobulin to detect monoclonal components in serum. J Coll Physicians Surg Pak 2021; 31(07):864-867","paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"This is division of the Positive patients.","title":"Type of positive serum electrophoresis and immunofixation patients","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"4"},{"groupId":"BG003","value":"10"}],"title":"Yes"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"2"}],"title":"No"}]}],"description":"PI (proteasome inhibitor) refractory is disease that is non-responsive to therapy with bortezomib, or progressing within 60 days of cessation of the most recent bortezomib therapy in patients who have achieved minimal response (MR) or better.","paramType":"COUNT_OF_PARTICIPANTS","title":"PI refractory","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"6"},{"groupId":"BG003","value":"10"}],"title":"Yes"},{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"2"}],"title":"No"}]}],"description":"IMiD (immunomodulatory drug) refractory is disease that is non-responsive to therapy with lenalidomid, or progressing within 60 days of cessation of the most recent lenalidomid therapy in patients who have achieved minimal response (MR) or better.","paramType":"COUNT_OF_PARTICIPANTS","title":"IMiD refractory","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"4"},{"groupId":"BG003","value":"8"}],"title":"Yes"},{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"4"}],"title":"No"}]}],"description":"Double refractory is disease that is non-responsive to therapy with either bortezomib or lenalidomide, or progressing within 60 days of cessation of the most recent therapy with either bortezomib or lenalidomide in patients who have achieved minimal response (MR) or better.","paramType":"COUNT_OF_PARTICIPANTS","title":"Double refractory (bortezomib/lenalidomide)","unitOfMeasure":"Participants"}],"populationDescription":"Because we obtained preclinical data indicating a synergistic effect between leflunomide and lenalidomide, we determined that investigating leflunomide-based combinational therapy was favorable over pursuing a phase 2 study of single-agent leflunomide. There were no dose de-escalations, so there were no patients accrued to the arms for 10mg, 30mg, or 50mg."}