{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"14"},{"groupId":"OG001","value":"13"}],"units":"Participants"}],"description":"Response was defined:\n\n* In patients with a serum M-protein \\> 5 g/l, as a reduction of at least 25% (minor response according to European society for Blood and Marrow Transplantation (EBMT)) from baseline of serum M-protein confirmed on two consecutive determinations at 4 weeks interval;\n* In patients with a serum M-protein ≤ 5 g/l and ≥ 3g/l, as a negative electrophoresis\n* In patients with serum M-protein \\< 3 g/l but a measurable involved serum free light chains ≥ 100 mg/l and an abnormal Free Light Chains ratio (\\<0.26 or \\> 1.65), as a ≥ 50 % decrease in the difference between involved and uninvolved Free Light Chains levels.","groups":[{"description":"every 4 weeks by intravenous route over 1 hour, for 4 or up to 8 cycles.","id":"OG000","title":"Arm A: IPH2101 0.2mg/Kg"},{"description":"every 4 weeks by intravenous route over 1 hour, for 4 or up to 8 cycles.","id":"OG001","title":"Arm B: IPH2101 2mg/kg"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"From the start of the treatment to the End of Study and during the post study follow up during 2 years according to standard practices","title":"Rate of Patients Achieving a Response Based on M-protein or Free Light Chains","type":"PRIMARY","unitOfMeasure":"participants"}