{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"5"}],"units":"Participants"}],"description":"Toxicity will be assessed by adverse events count during NKAE treatment monitoring peripheral blood absolute neutrophil count (cells/μl). Toxicity will be evaluated monthly during NKAE treatment (4 months). During follow-up, it will be assessed monthly the first 6 months. After that, quarterly until one year of follow-up, based on Common Toxicity Criteria for Adverse Events of the National Cancer Institute (CTCAE) to v.4.03.","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","populationDescription":"Analysis per protocol","reportingStatus":"POSTED","timeFrame":"16 months","title":"Number of Participants With Adverse Events During NKAE Treatment","type":"PRIMARY","unitOfMeasure":"participants"}