Two randomized open-label studies of daratumumab (DARA) plus standard of care treatment versus standard of care alone in patients with previously untreated multiple myeloma (MM) ineligible for high-dose therapy: 54767414MMY3007 (Alcyone) and 54767414MMY3008 (Maia)

Abstract

e294 dose adjustments were required prior to rollover, per protocol. Pts were followed for up to 5 years (yrs; including 1 yr spent in MM-021). Baseline ISS stage was calculated for all MM-021 pts with available data (N1⁄4 197). Efficacy and safety data for MM-021 pts that did not carry over to MM-024 (N1⁄4119) was combined with data for pts that carried over (N1⁄4 80, data cutoff November 5, 2014). Results:Of the 197 evaluable pts at baseline in the MM-021 study, 83, 52, and 62 pts had ISS stage I, II, and III MM, respectively. Median (range) age of pts with ISS stage I, II, and III MM was 59 yrs (35e81), 61 yrs (37e76), and 59 yrs (35e77), respectively; proportions of pts aged > 65 yrs were 28%, 33%, and 27%. Median number of Rd cycles decreased as ISS stage increased: 12.0, 9.5, and 6.0 cycles for ISS stage I, II, and III, respectively. ORRs were 50.6%, 59.6%, and 40.3%, respectively. Median DOR of responders was higher for ISS stage I MM pts vs those with stage II or III (Table). Median PFS and OS decreased as ISS stage increased. Gr 3e4 AEs were reported in 59.0%, 80.8%, and 82.3% of pts with ISS stage I, II, and III MM, respectively. Few pts discontinued study treatment due to AEs (3.6%, 0%, and 11.3% of pts, respectively). There was a trend toward an increased incidence of Gr 3e4 hematologic AEs in higher ISS stage pts. Conclusion: Clinical benefit was observed in patients treated with Rd, regardless of ISS stage. Lower baseline ISS stage predicted longer PFS and OS in Chinese pts with RRMM treated with Rd. This abstract was developed with editorial support from Excerpta Medica. Table Summary of efficacy and safety outcomes according to ISS MM stage