{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.2135","upperLimit":"0.5025","value":"0.3478"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"46"}],"units":"Participants"}],"description":"This will be estimated by the number of patients who achieve MRD negative status by flow cytometry (MPF) in the bone marrow after 1 year of maintenance therapy divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true rate of MRD negative response after 1 year of maintenance will be calculated.","dispersionType":"95% Confidence Interval","groups":[{"description":"Patients receive daratumumab IV on days 1, 8, 15, and 22 of cycles 1-2, and on days 1 and 15 of cycles 3-4. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Beginning 8 weeks after completion of daratumumab cycle 2 or 4, patients undergo ASCT. Within 14 days after completion of day 100 visit post-SCT, patients receive daratumumab IV on day 1 and lenalidomide PO daily on days 1-21. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients who are still maintaining response continue to receive daratumumab IV every 3 months in the absence of disease progression or unacceptable toxicity.","id":"OG000","title":"Treatment (Daratumumab, ASCT, Lenalidomide)"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"1 year","title":"Rate of MRD Negative Response After 1 Year (12 Courses) of Daratumumab and Lenalidomide Maintenance","type":"SECONDARY","unitOfMeasure":"proportion of participants"}