{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"5"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"5"}],"units":"Participants"}],"description":"Efficacy will be assessed monthly during NKAE treatment (4 months) by peripheral blood monoclonal protein monitoring. During follow-up, efficacy will be evaluated monthly the first 6 months. After that, quarterly until one year of follow-up.","groups":[{"description":"Expanded and activated autologous NK cells (NKAEs) + chemotherapy (lenalidomide OR bortezomib).\n\nNKAE cells infusion: Expanded and activated autologous NK cells infusion. Each patient will receive two infusions of 7.5 x 106 expanded and activated autologous NK cells/kg/cycle.\n\nLenalidomide: Lenalidomide, 10 mg oral/day during 21 days (cycle). Patients will receive 4 cycles.\n\nBortezomib: bortezomib, 1.3 mg/m2, s.c., days 1, 4, 8 and 11/cycle. Patients will receive 4 cycles.","id":"OG000","title":"NKAE Cells Infusion + Chemotherapy"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"16 months","title":"Number of Participants With Peripheral Blood Monoclonal Protein Reduction or Stabilization","type":"SECONDARY","unitOfMeasure":"participants"}