Outcomes and assessments
PD, death, TTP, Cancer
ADVERSE EVENT, MYELOMA, ADVERSE EVENTS, TTP, DISEASE, REMISSION, ADVERSE EVENT, T(4;14), DELETION, T(14;16), DISEASE, CANCER
The primary endpoint was PFS, defined as the time from the date of the randomization to the date of the first documented PD or death from any cause during the study, whichever occurred first. Secondary endpoints included overall survival (OS), ORR, duration of response (DOR), time to response (TTR), time to progression (TTP), safety, and health-related quality of life (HRQoL). The exploratory endpoint was to evaluate the efficacy among high-risk patients defined as [t(14;16)], [t(4;14)], or [del(17p)] by fluorescence in situ hybridization, or chromosome 13 deletion with hypodiploidy by G-band staining [Serum and urine monoclonal proteins and serum free light chain levels were measured at a central laboratory. Disease status were assessed by the investigators at the baseline and the end of each cycle. The International Myeloma Working Group consensus criteria (IMWG criteria) were used to assess responses and PD. For patients in remission, if treatment was discontinued due to intolerable adverse event (AE) or the completion of 18 cycles of treatment, the disease status was assessed every six weeks until PD, death or next anti-myeloma therapy started. We required all responses and PD be assessed by IAC. PFS, ORR, DOR, TTR, and TTP were calculated based on the responses and PD assessed by IAC.The HRQoL questionnaires were completed at baseline and the end of every cycle using the European Organization for Research and Treatment of Cancer (EORTC) questionnaires: the generic EORTC QLQ-C30 and the myeloma-specific QLQ-MY20.The AEs and serious adverse events (SAEs) were collected up to 28 days following the last treatment dose and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03.