{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}],"title":"Complete response"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"11"}]}],"title":"Partial response"},{"categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"11"}]}],"title":"Minimal response"},{"categories":[{"measurements":[{"groupId":"OG000","value":"41"},{"groupId":"OG001","value":"61"}]}],"title":"Stable Disease/No changes"},{"categories":[{"measurements":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"17"}]}],"title":"Progressive Disease/Treatment failure"}],"denoms":[{"counts":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"18"}],"units":"Participants"}],"description":"Complete response(CR):0 percentage the original monoclonal protein level from blood and urine Partial response(PR): ≥50 percentage reduction in the level of serum monoclonal protein Minimal response(MR):≥25 percentage to ≤ 49 percentage reduction in the level of serum monoclonal protein Stable disease: Not meeting the criteria for MR or PD. Progressive disease: \\>25 percentage increase in level of serum monoclonal paraprotein, which must also be an absolute increase of at least 5 g/L and confirmed on a repeat investigation.\n\nTreatmen failure: Reappearance of serum or urinary paraprotein","groups":[{"description":"Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks.","id":"OG000","title":"Plitidepsin"},{"description":"Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks plus 20 mg of oral dexamethasone every day on days 1 to 4 of each cycle, starting at the same time than the plitidepsin infusion.","id":"OG001","title":"Plitidepsin + Dexamethasone"}],"paramType":"NUMBER","populationDescription":"Per protocol - Only 29 of 32 and 18 of 19 enrolled patients were evaluable (analyzed patients)","reportingStatus":"POSTED","timeFrame":"Every 2 weeks until progression or death occurs.","title":"Objective Response Rate (ORR), Defined as the Combined Rate of Complete Response, Partial Response and Minimal Response","type":"PRIMARY","unitOfMeasure":"percentage patients"}