Daratumumab with lenalidomide as maintenance after transplant in newly diagnosed multiple myeloma: the AURIGA study.

No randomized trial has directly compared daratumumab and lenalidomide (D-R) maintenance with standard-of-care lenalidomide (R) alone after transplant.

Herein, we report the primary results of the phase 3 AURIGA study evaluating D-R vs R maintenance in patients with newly diagnosed multiple myeloma (NDMM) who had very good or better partial response, were minimal residual disease (MRD)-positive (10-5) and anti-CD38-naïve after transplant.

Two hundred patients were randomly assigned (1:1) to D-R (n = 99) or R (n = 101) maintenance for up to 36 cycles. The MRD-negative (10-5) conversion rate by 12 months from start of maintenance (primary end point) was significantly higher for D-R than R (50. 5% vs 18. 8%; odds ratio [OR], 4.

51; 95% confidence interval [CI], 2. 37-8. 57; P < . 0001). MRD-negative (10-6) conversion rate was similarly higher with D-R (23. 2% vs 5. 0%; OR, 5. 97; 95% CI, 2. 15-16. 58; P = . 0002). At median follow-up (32.

3 months), D-R achieved a higher overall MRD-negative (10-5) conversion rate (D-R, 60. 6% vs R, 27. 7%; OR, 4. 12; 95% CI, 2. 26-7. 52; P < . 0001) and complete response rate or better (75. 8% vs 61. 4%; OR, 2. 00; 95% CI, 1. 08-3. 69; P = . 0255) vs R.

Progression-free survival (PFS) favored D-R vs R (hazard ratio, 0. 53; 95% CI, 0. 29-0. 97); estimated 30-month PFS rates were 82. 7% for D-R and 66. 4% for R. Incidences of grade 3/4 cytopenias (54. 2% vs 46. 9%) and infections (18. 8% vs 13. 3%) were slightly higher with D-R than R.

In conclusion, D-R maintenance achieved a higher MRD-negative conversion rate and improved PFS after transplant vs R, with no new safety concerns. This trial was registered at www. clinicaltrials. gov as #NCT03901963.