{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0","upperLimit":"0.28","value":"0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"11"}],"units":"Participants"}],"description":"The International Myeloma Working Group response criteria was used to assess response to therapy. The proportion of VGPR response at any time during treatment with pembrolizumab added to lenalidomide and dexamethasone will be estimated by the number of patients achieving a VGPR, CR, or sCR at any time divided by the total number of evaluable patients. A very good partial response (VGPR) is defined as as a demonstration of:\n\n* Serum and urine M-component detectable by immunofixation but not on electrophoresis c or\n* greater than 90% reduction in serum m-component and urine m-component \\<100 mg/24 h\n* If the only measurable disease is FLC, a ≥90% reduction in the difference between involved and involved FLC levels\n\nThe proportion of successes will be estimated by the number of patients demonstrating a VGPR or better divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.","dispersionType":"95% Confidence Interval","groups":[{"description":"Patients receive 25 mg lenalidomide PO daily on days 1-21 and 40 mg dexamethasone PO daily on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive 200 mg pembrolizumab IV over 30 minutes on days 1 and 22 of course 1, day 15 of course 2, and day 8 of course 3. Courses 1-3 repeat beyond 3 courses in the absence of disease progression or unacceptable toxicity. Patients may undergo stem cell transplantation after 4 courses of treatment.","id":"OG000","title":"Treatment (Lenalidomide, Dexamethasone, Pembrolizumab)"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"Up to 112 days","title":"Proportion of Complete Response Plus Very Good Partial Response (VGPR)","type":"PRIMARY","unitOfMeasure":"proportion of participants"}