Fig. 2. Subgroup analysis of MRD-negativity (10⁻⁵) rates among patients with a best response of ≥ CR by the end of the study.

MRD-negativity rates were evaluated among response-evaluable patients^a who achieved a best response of ≥ CR and were measured at the time of the final analysis (median follow-up in overall population, 49.6 months). MRD was evaluated by next-generation sequencing using the clonoSEQ assay (v2.0; Adaptive Biotechnologies, Seattle, WA) at a minimum sensitivity threshold of 1 in 100,000 cells (10⁻⁵) in alignment with IMWG criteria [44]. MRD minimal residual disease, D-RVd daratumumab plus lenalidomide/bortezomib/dexamethasone, RVd lenalidomide/bortezomib/dexamethasone, CI confidence interval, ITT intent-to-treat, ISS International Staging System, HRCA high-risk cytogenetic abnormality, NE not evaluable, VGPR very good partial response, FISH fluorescence in situ hybridization. ^aMantel–Haenszel estimate of the common odds ratio for unstratified tables is used. An odds ratio > 1 indicates an advantage for D-RVd. ^bThis analysis included patients from the response-evaluable population, which included all randomized patients who had measurable disease (confirmed MM diagnosis), received ≥ 1 dose of study treatment, and had ≥ 1 postbaseline disease assessment. ^cHigh-risk cytogenetics are defined based on FISH testing as ≥ 1 of the following: del(17p), t(4;14), or t(14;16). ^dRevised high-risk cytogenetics are defined based on FISH testing as ≥ 1 HRCA: del(17p), t(4;14), t(14;16), t(14;20), or gain/amp(1q21) (≥ 3 copies of chromosome 1q21). ^ePatients in this group have gain/amp(1q21) with or without other HRCAs (del[17p], t[4;14], t[14;16], or t[14;20]). ^fPatients with isolated gain/amp(1q21) do not have any other HRCAs.