{"analyses":[{"ciNumSides":"TWO_SIDED","groupDescription":"No patients obtained a 50% reduction in M-protein concentration and the study did not continue to the second stage of enrollment due to the lack of efficacy as defined by out criteria. This statistical analysis includes all participants (i.e., stable disease (SD), minimal response (MR), biochemical progression (BP), and progressive disease (PD)).","groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.56","statisticalMethod":"Wilcoxon (Mann-Whitney)"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"11"}]}],"title":"Minimal Response (MR)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"66"}]}],"title":"Stable Disease (SD)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"11"}]}],"title":"Biochemical Progression (BP)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"11"}]}],"title":"Progressive Disease (PD)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"9"}],"units":"Participants"}],"description":"Response rate is defined as the percentage of participants with a 50% decline in monoclonal protein (M-protein) assessed by the International Multiple Myeloma Working Group (IMWG) for multiple myeloma (MM) criteria. Minimal response (MR) is MR \\>25% and \\<50% decrease in M-protein. Biochemical progression (BP) is asymptomatic, ≥ 25% M-protein increase from baseline and an absolute increase of M-protein of 0.75 g/dL demonstrated on two separate occasions. Progressive disease (PD), (clinical progression to symptomatic MM) is development of CRAB (hyperCalcemia (corrected calcium \\>2.75 mmol/L), Renal insufficiency (attributed to MM), Anemia (hemoglobin \\<10g/dL), and Bone lesions (lytic lesions or osteoporosis with compression fractures) criteria end organ damage. Stable disease (SD) is not meeting the criteria for minimal response, biochemical progression and progressive disease.","groups":[{"description":"Patients will receive anti-KIR(IPH2101) (1mg/kg) every other month for 6 cycles\n\n(Anti-KIR): Patients will receive anti-KIR(IPH2101) (1mg/kg) every other month for 6 cycles","id":"OG000","title":"Anti-KIR in Smoldering Multiple Myeloma Patients"}],"paramType":"NUMBER","populationDescription":"Study stopped after the first stage due to the lack of patients meeting the defined primary objective (50% decline in M-protein).","reportingStatus":"POSTED","timeFrame":"1 year","title":"Response Rate","type":"PRIMARY","unitOfMeasure":"percentage of participants"}