By: Kerri Fitzgerald
The phase 3 MIDAS study is assessing a measurable residual disease (MRD)-driven consolidation and maintenance strategy for patients with newly diagnosed multiple myeloma (NDMM). The primary results showed that after six induction cycles with isatuximab, carfilzomib, lenalidomide, and dexamethasone (IsaKRD) in NDMM patients who achieved MRD negativity at 10⁻⁵, MRD negativity rates at 10⁻⁶ before maintenance were not significantly different between a transplant-based approach versus IsaKRD consolidation alone.
In patients who do not achieve MRD negativity at 10⁻5, tandem autologous stem cell transplantation (ASCT) did not significantly improve MRD negativity rates at 10⁻⁶ before maintenance. Aurore Perrot, MD, PhD, of the University of Toulouse in France, presented initial findings at the 2025 ASCO(R) Annual Meeting.
The multicenter, open-label, randomized, phase 3 MIDAS trial includes transplant-eligible patients ages 18 to 65 with NDMM. Patients (n=485) achieving post-induction MRD negativity at a threshold of 10⁻⁵ were randomized to:
- Arm A: six additional cycles of IsaKRD (n=243)
- Arm B: ASCT followed by two cycles of IsaKRD (n=242)
Both cohorts then received lenalidomide maintenance.
After induction, MRD-positive patients (n=233; defined as MRD ≥10⁻⁵) were randomized to:
- Arm C: Single ASCT plus two cycles of IsaKRD (n=109)
- Arm D: Tandem ASCT (n=124)
Both cohorts then received isatuximab plus iberdomide maintenance.
During consolidation, five patients experienced disease progression (two in arm A and three in arm D), and two patients died without disease progression in arm A. No new safety signals were identified compared to the induction phase.
With a median follow-up of 16.8 months in arms A and B and 16.3 months in arms C and D, sustained MRD negativity and progression-free survival data are not yet available.
Premaintenance MRD negativity rates at 10⁻⁶ were 84% in arm A and 86% in arm B (odds ratio [OR], 1.17; P=0.64) and 40% in arm C and 32% in arm D (OR, 0.73; P=0.31).
The study is ongoing to evaluate the long-term outcomes of this MRD-adapted strategy.
Reference
Perrot A, Hulin C, Lambert J, et al. MRD-driven strategy following IsaKRD induction in transplant-eligible NDMM: primary endpoints of the phase 3 MIDAS trial. Abstract #7500. Presented at the 2025 ASCO(R) Annual Meeting; May 30-June 3, 2025; Chicago.
