{"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"description":"Progression-free survival defined as the time from randomization until the earlier of progression or death due to any cause, or censored at date of last disease evaluation.\n\nProgression is defined as one of the following criteria is met.\n\n* Increase of ≥ 25% from lowest value reported in serum M-component (the absolute increase must be ≥ 0.5 g/dL) and/or urine M-component (the absolute increase must be ≥ 200 mg/ 24 hours).\n* Only in patients without measurable serum and urine M protein levels: the difference between involved and uninvolved FLC levels. The absolute increase must be \\> 10 mg/dL.\n* If the only measurable disease is bone marrow, bone marrow plasma cell percentage: the absolute % must be ≥ 10%.\n* Development of new bone lesions or soft tissue plasmacytomas or ≥ 50% increase from nadir in the size (SPD) of existing bone lesions or soft tissue plasmacytoma or ≥ 50% increase in the longest diameter of a previous lesion \\> 1cm in short axis.","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":"Progression-free Survival (PFS)","type":"SECONDARY"}