MAIA, ALCYONE Trials: Sustained MRD Negativity “Associated with Improved PFS” in Transplant-Ineligible NDMM

After a median follow-up of more than 3 years, daratumumab-based therapies were associated with higher rates and durability of MRD negativity, while durable MRD negativity was in turn associated with improved progression-free survival (PFS) in patients with transplant-ineligible newly diagnosed multiple myeloma (NDMM), according to the results of the international Phase 3 MAIA and ALCYONE clinical trials, which were published in Blood in July.  

In MAIA, the addition of daratumumab to lenalidomide and dexamethasone reduced the risk of disease progression or death by 44% after 36.4 months of follow-up. In ALCYONE – in which daratumumab was added to bortezomib, melphalan, and prednisone – the risk of disease progression or death was reduced by 58% in the daratumumab arm after 40.1 months of follow-up. The two trials enrolled a total of more than 1,400 patients in more than a dozen countries.

Regardless of treatment assignment, MRD-negative status and sustained MRD negativity lasting more than 6 months and more than 12 months were associated with improved PFS. The addition of daratumumab resulted in higher rates of MRD negativity lasting for 6 months or longer, which translated to improved PFS compared with control groups that did not receive daratumumab.

In a pooled analysis, MRD-negative patients had improved PFS compared with those who were MRD positive. Patients who achieved MRD-negative status or sustained MRD negativity had deep remission and improved clinical outcomes.

  • San-Miguel JF, Avet-Loiseau H, Paiva B, et al. Sustained Minimal Residual Disease Negativity With Daratumumab in Newly Diagnosed Multiple Myeloma: MAIA and ALCYONE [published online ahead of print, 2021 Jul 16]. Blood. 2021;blood.2020010439. doi:10.1182/blood.2020010439

Tags: MRD, Association, transplantation, Transplant, PFS, improvement, trials, MRD negativity, ineligible, NDMM