{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"60"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"12"}],"units":"Participants"}],"description":"Observed toxicities will be summarized, for all dose levels, in terms of type (organ affected or laboratory determination), severity, time of onset, duration, serum concentration of the active leflunomide metabolite, probable association with the study treatment and reversibility or outcome.","groups":[{"description":"Patients receive 20, 40 or 60 mg leflunomide PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.","id":"OG000","title":"All Participants"}],"paramType":"NUMBER","populationDescription":"Recommended phase 2 dose: This was the highest planned dose level within this study. 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.","reportingStatus":"POSTED","timeFrame":"28 days","title":"MTD, Defined as the Highest Dose in Which =< 1/6 Patients Experience a Dose-limiting Toxicity, Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03","type":"PRIMARY","unitOfMeasure":"mg"}