{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"10"}]}],"title":"Complete Response"},{"categories":[{"measurements":[{"groupId":"OG000","value":"8"}]}],"title":"Near Complete Response"},{"categories":[{"measurements":[{"groupId":"OG000","value":"10"}]}],"title":"Partial Response"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}],"title":"Stable Disease"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"}]}],"title":"Progression of Disease"},{"categories":[{"measurements":[{"groupId":"OG000","value":"7"}]}],"title":"Very Good Partial Response"}],"denoms":[{"counts":[{"groupId":"OG000","value":"40"}],"units":"Participants"}],"description":"The response of myeloma to BDDTD will be assessed by standard electrophoretic and immunofixation tests of blood and urine for a monoclonal protein (M protein), and bone marrow aspirate and biopsy. These tests will be performed at enrollment and at the conclusion of therapy.","groups":[{"description":"Combination therapy with bortezomib, pegylated liposomal doxorubicin and dexamethasone (BDD) followed by either thalidomide and dexamethasone (TD) or bortezomib, thalidomide and dexamethasone in patients with symptomatic untreated high-risk or primary resistant multiple myeloma. Three cycles of BDD will be administered. Patients who respond after three cycles will receive two cycles of TD. Patients with stable or progressive disease after three cycles of BDD receive two cycles of bortezomib, thalidomide and dexamethasone. If at any point during the study a patient achieves a complete response (CR), the patient will be given the option to discontinue treatment on-study.","id":"OG000","title":"Combination Therapy"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"2 years","title":"Disease Response","type":"PRIMARY","unitOfMeasure":"participants"}