{"analyses":[{"ciLowerLimit":"0.30","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.01","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","paramType":"Odds Ratio (OR)","paramValue":"0.55"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"30.5","upperLimit":"49.7","value":"39.8"},{"groupId":"OG001","lowerLimit":"43.6","upperLimit":"65.0","value":"54.4"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"108"},{"groupId":"OG001","value":"90"}],"units":"Participants"}],"description":"Bone marrow aspirate samples were obtained from patients prior to the start of lenalidomide maintenance. NGS MRD- rate is the percentage of evaluable participants with MRD level of \\<1 x 10-5 (indicating detection of 1 malignant plasma cell in 100,000 bone marrow cells) using the validated, US Food and Drug Administration approved clonoSEQ® NGS platform (Adaptive Biotechnologies) with a minimum sensitivity of 1 x 10-5.","dispersionType":"95% Confidence Interval","groups":[{"description":"All participants received one cycle of Lenalidomide (R), bortezomib (V) and dexamethasone (D) and then were randomized. All participants then received two additional RVD cycles, followed by stem-cell collection. RVD Alone participants received five additional RVD cycles. Maintenance in both arms comprised daily lenalidomide 10 mg, escalated to 15 mg if tolerated, until disease progression, unacceptable toxicity, or withdrawal from treatment or study. After finishing protocol-specified treatment, off-study salvage transplantation was recommended but not mandated for RVD Alone participants at relapse.\n\nRVD cycle duration=21 days R: 25 mg oral on days 1-14 V: 1.3 mg per square meter of body surface area IV or subcutaneous on days 1, 4, 8, and 11 D: 20 mg oral (cycles 1-3) or 10 mg (cycles 4-8) on days 1, 2, 4, 5, 8, 9, 11, and 12","id":"OG000","title":"RVD Alone"},{"description":"All participants received one cycle of Lenalidomide (R), bortezomib (V) and dexamethasone (d) and then were randomized. All participants then received two additional RVD cycles, followed by stem-cell collection. RVD plus autologous stem cell transplant (ASCT) participants received high-dose melphalan (200 mg/m2, adjusted for ideal body weight) ASCT and, upon recovery (\\~day 60), two additional RVD cycles. Maintenance in both arms comprised daily lenalidomide 10 mg, escalated to 15 mg if tolerated, until disease progression, unacceptable toxicity, or withdrawal from treatment or study.\n\nAfter finishing protocol-specified treatment, RVD plus ASCT participants could undergo a second transplant.\n\nRVD cycle duration=21 days R: 25 mg oral on days 1-14 V: 1.3 mg per square meter of body surface area IV or subcutaneous on days 1, 4, 8, and 11 D: 20 mg oral (cycles 1-3) or 10 mg (cycles 4-8) on days 1, 2, 4, 5, 8, 9, 11, and 12","id":"OG001","title":"RVD Plus ASCT"}],"paramType":"NUMBER","populationDescription":"The analysis population is comprised of the participants with evaluable samples at baseline and start of maintenance.","reportingStatus":"POSTED","timeFrame":"Maintenance treatment occurred after induction, up to 11.5 months.","title":"Next Generation Sequencing (NGS) Minimal Residual Disease Negative (MRD-) Rate at Maintenance Start","type":"POST_HOC","unitOfMeasure":"percentage of participants"}