{"analyses":[{"groupIds":["OG000","OG001","OG002","OG003","OG004","OG005"],"nonInferiorityType":"OTHER","pValue":"0.015","statisticalMethod":"Fisher-Freeman-Halton exact test"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"2"},{"groupId":"OG004","value":"3"},{"groupId":"OG005","value":"0"}],"title":"MY-RADS RAC 1: Highly likely to be responding"},{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"4"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"}],"title":"MY-RADS RAC 2: Likely to be responding"},{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"8"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"1"},{"groupId":"OG005","value":"1"}],"title":"MY-RADS RAC 3: Stable"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"8"},{"groupId":"OG003","value":"9"},{"groupId":"OG004","value":"4"},{"groupId":"OG005","value":"1"}],"units":"Participants"}],"description":"Secondary Objective 1: To assess whether the novel Magnetic Resonance (MR) protocol can improve detection of longitudinal changes in tumour burden in patients with new or relapsed myeloma during therapy, compared to the International Myeloma Working Group (IMWG) Response Group classification alone.\n\nThis section compared two indicators of therapy response:\n\n1. IMWG Response Group classification \\[1\\], based on % change in serum paraprotein\n2. MY-RADS RAC (Myeloma Response Assessment and Diagnosis System Response Assessment Classification) based on expert radiologist interpretation of paired novel MR imaging, guided by Messiou et. al. criteria \\[2\\].\n\nRef:\n\n1. https://www.myeloma.org/resource-library/international-myeloma-working-group-imwg-uniform-response-criteria-multiple\n2. Messiou, Christina, et al. \"Guidelines for acquisition, interpretation, and reporting of whole-body MRI in myeloma: myeloma response assessment and diagnosis system (MY-RADS).\" Radiology 291.1 (2019): 5-13.","groups":[{"description":"IMWG classification of therapy response","id":"OG000","title":"IMWG: Relapse"},{"description":"IMWG classification of therapy response","id":"OG001","title":"IMWG: Progressive"},{"description":"IMWG classification of therapy response","id":"OG002","title":"IMWG: Stable"},{"description":"IMWG classification of therapy response","id":"OG003","title":"IMWG: Partial Response"},{"description":"IMWG classification of therapy response","id":"OG004","title":"IMWG: Very Good Partial Response"},{"description":"IMWG classification of therapy response","id":"OG005","title":"IMWG: Complete Response"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Participants from Group 1 who had successfully measured paired novel MR scans and serum paraproteins, between baseline and 6-month follow-up, and with a successfully graded MY-RADS RAC, and IMWG Response Group classifications.","reportingStatus":"POSTED","timeFrame":"Comparison between baseline and follow-up at 6 months.","title":"Secondary Outcome 1: Detect Longitudinal Changes in Tumour Load With Therapy [MY-RADS RAC (Myeloma Response Assessment and Diagnosis System Response Assessment Classification) vs IMWG (International Myeloma Working Group) Response Group Classification]","type":"SECONDARY","unitOfMeasure":"Participants"}