{"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"description":"Response is evaluated based on standard International Myeloma Working Group (IMWG) criteria and tabulated by category. Response (stringent complete response \\[sCR\\], complete response \\[CR\\], very good partial response \\[VGPR\\]) is defined as below.\n\nsCR: All CR criteria and the following have to be met. Normal serum FLC ratio at two consecutive times and absence of clonal cells in bone marrow by immunohistochemistry or 2- to 4- color flow cytometry. Presence/absence of clonal cells is based upon the κ/λ ratio. An abnormal κ/λ ratio by immunohistochemistry requires a minimum of 100 plasma cells for analysis. An abnormal ratio reflecting presence of an abnormal clone is κ/λ ratio of 4:1 or 1:2.\n\nCR: Complete disappearance of an Mprotein and no evidence of myeloma in the bone marrow.\n\nVGPR: Serum M-protein detectable by immunofixation but not quantifiable on electrophoresis and urine M-protein \\< 100 mg/24 hours","groups":[{"description":"Patients receive lenalidomide PO QD on days 1-28 and ixazomib citrate PO on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow aspirate and/or biopsy and PET and CT scan at screening and on study as well as undergo collection of blood samples throughout the trial.\n\nBiospecimen Collection: Undergo collection of blood samples\n\nBone Marrow Aspirate: Undergo bone marrow aspirate\n\nBone Marrow Biopsy: Undergo bone marrow biopsy\n\nComputed Tomography: Undergo CT scan\n\nIxazomib Citrate: Given PO\n\nLenalidomide: Given PO\n\nQuality-of-Life Assessment: Ancillary studies\n\nQuestionnaire Administration: Ancillary studies","id":"OG000","title":"Arm A (Lenalidomide, Ixazomib Citrate)"},{"description":"Patients receive lenalidomide PO QD on days 1-28 and a placebo PO on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow aspirate and/or biopsy and PET and CT scan at screening and on study as well as undergo collection of blood samples throughout the trial.\n\nBiospecimen Collection: Undergo collection of blood samples\n\nBone Marrow Aspirate: Undergo bone marrow aspirate\n\nBone Marrow Biopsy: Undergo bone marrow biopsy\n\nComputed Tomography: Undergo CT scan\n\nLenalidomide: Given PO\n\nPlacebo Administration: Given PO\n\nPositron Emission Tomography: Undergo PET scan\n\nQuality-of-Life Assessment: Ancillary studies\n\nQuestionnaire Administration: Ancillary studies","id":"OG001","title":"Arm B (Lenalidomide, Placebo)"}],"populationDescription":"Only one patient was enrolled on this study. Due to confidentiality reasons, individual data was not reported.","reportingStatus":"POSTED","timeFrame":"Assessed every 3 months if patient is <2 years from randomization, every 6 months if patient is 2-5 years from randomization, annually if patient is 5 years or more from randomization.","title":"Best Response on Treatment","type":"SECONDARY"}