{"denoms":[{"counts":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"}],"units":"Participants"}],"groups":[{"description":"Cohort A will consist of subjects who are ibrutinib naïve and appropriate for ibrutinib based treatment. Treatment naïve subjects will be eligible to enroll in this cohort. All subjects in this cohort will receive ibrutinib plus daratumumab\n\nIbrutinib: Ibrutinib, 420mg orally, once daily\n\nDaratumumab: Daratumumab, 16 mg/kg intravenously, weekly for 8 weeks, bi weekly for 16 weeks, then monthly for up to 19 months.","id":"BG000","title":"Cohort A - Ibrutinib Naive"},{"description":"Cohort B will consist of subjects who have had at least 6 months of exposure to single agent ibrutinib and who have demonstrated an IgM response plateau defined by two IgM measurements, at least 8 weeks apart that have changed \\<15% from the previous mark. All subjects in this cohort will receive ibrutinib plus daratumumab\n\nIbrutinib: Ibrutinib, 420mg orally, once daily\n\nDaratumumab: Daratumumab, 16 mg/kg intravenously, weekly for 8 weeks, bi weekly for 16 weeks, then monthly for up to 19 months.","id":"BG001","title":"Cohort B - Ibrutinib Response Plateau"},{"description":"Total of all reporting groups","id":"BG002","title":"Total"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"<=18 years"},{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"}],"title":"Between 18 and 65 years"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":">=65 years"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Age, Categorical","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG002","value":"1"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG002","value":"0"}],"title":"Male"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Sex: Female, Male","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG002","value":"0"}],"title":"Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG002","value":"1"}],"title":"Not Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG002","value":"0"}],"title":"Unknown or Not Reported"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Ethnicity (NIH/OMB)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG002","value":"0"}],"title":"American Indian or Alaska Native"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG002","value":"0"}],"title":"Asian"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG002","value":"0"}],"title":"Native Hawaiian or Other Pacific Islander"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG002","value":"0"}],"title":"Black or African American"},{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG002","value":"1"}],"title":"White"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG002","value":"0"}],"title":"More than one race"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG002","value":"0"}],"title":"Unknown or Not Reported"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Race (NIH/OMB)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG002","value":"1"}]}],"title":"United States"}],"paramType":"NUMBER","title":"Region of Enrollment","unitOfMeasure":"participants"}],"populationDescription":"0 subjects were enrolled in Cohort B."}