{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"33","upperLimit":"64","value":"49"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"39"}],"units":"Participants"}],"description":"A success is defined to be an objective status of CR after completion of 6 cycles of treatment. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. A 95% confidence interval for the true overall CR rate will be calculated according to the method of Duffy and Santner.","dispersionType":"95% Confidence Interval","groups":[{"description":"Patients receive cyclophosphamide IV, doxorubicin hydrochloride IV and vincristine sulfate IV on day 1, etoposide IV over 30-60 minutes on days 1-3, prednisone PO on days 1-5, and lenalidomide PO on days 1-10. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients responding after 6 courses of treatment may then undergo an autologous stem cell transplant or receive maintenance lenalidomide at the discretion of the physician or patient choice as follows:\n\nTRANSPLANT: Patients undergo autologous stem cell transplant per standard of care.\n\nMAINTENANCE LENALIDOMIDE: Patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.\n\nAutologous Hematopoietic Stem Cell Transplantation: Undergo autologous stem cell transplant\n\nCyclophosphamide: Given IV\n\nDoxorubicin Hydrochloride: Given IV\n\nEtoposide: Given IV\n\nLaboratory Biomarker Analysis: Correlative studies\n\nLenalidomide: Given PO\n\nPeripheral Blood Stem Cell Transplantation: Undergo peripheral blood stem cell transplant\n\nPrednisone: Given PO\n\nVincristine Sulfate: Given IV","id":"OG000","title":"Treatment (Combination Chemotherapy, Lenalidomide)"}],"paramType":"NUMBER","populationDescription":"Assessment based on phase II patients given the maximum tolerated dose level (10 mg) as the Intent to treat (ITT) group of subjects. 39 subjects were dosed with 10 mg dose of Lenalidamide as the ITT group.","reportingStatus":"POSTED","timeFrame":"Up to the completion of course 6 (18 weeks)","title":"Complete Response Rate (Phase II)","type":"PRIMARY","unitOfMeasure":"percentage of participants"}