Skip to main content
IMS Events Main banner

    Treatment of Newly Diagnosed Myeloma (excluding t-cell redirection therapy)

    Category: Treatment of Newly Diagnosed Myeloma (excluding t-cell redirection therapy)

    Propensity Score–Matched Comparison of Daratumumab–Rd versus Daratumumab–VMP in Transplant-Ineligible Multiple Myeloma Patients with del(17p13): An Analysis of the MAIA and ALCYONE Trials

    (PA-394) Propensity Score–Matched Comparison of Daratumumab–Rd versus Daratumumab–VMP in Transplant-Ineligible Multiple Myeloma Patients with del(17p13): An Analysis of the MAIA and ALCYONE Trials

    Friday, September 19, 2025

    Introduction:      Outcomes in transplant-ineligible newly diagnosed multiple myeloma (NDMM) have improved with the incorporation of daratumumab-based regimens. However, prognosis remains poor for patients with high-risk cytogenetics, particularly del(17p13). Although the MAIA trial showed a survival benefit with D-Rd and the ALCYONE trial with D-VMP, no direct head-to-head comparison has been performed, particularly in this high-risk subgroup.

    Objective. To compare progression-free and overall survival of high-risk, transplant-ineligible NDMM patients treated with D-Rd, D-VMP, Rd, and VMP, using a propensity score–weighted analysis of pooled data from the MAIA and ALCYONE trials.



    Methods:   This retrospective analysis used de-identified patient-level data from the MAIA and ALCYONE phase III trials (YODA Project, DUA #2025-0152). Patients with confirmed del(17p13) were selected. One-to-two nearest-neighbor propensity score matching was performed based on age ≥70, ECOG 1–2, CLCR ≥60 mL/min, and ISS stage. Covariate balance was verified post-matching. Kaplan–Meier curves and log-rank tests were used to compare PFS and OS.

    Results:   Of 86 patients with del(17p13), 17, 16, 24, and 29 received D-Rd, Rd, VMP, and D-VMP. Median PFS was 40.9, 27.1, 23.1,, and 21.5 months (p = 0.59) (Figure 1A). The 3-year OS was 58.8 % (95 % CI 39.5–87.6 %), 56.2 % (36.5–86.7 %), 62.5 % (45.8–85.2 %), and 65.2 % (49.9–85.2 %) (Figure 1B). Post-matching balance diagnostics showed standardized mean differences < 0.25 across covariates. Maximum eCDF statistics were < 0.1, and variance ratios remained within acceptable limits (0.5–2.0), confirming distributional balance across matched treatment groups (D-Rd and D-VMP)(Figure 2). After matching, 26 patients were included in the analysis (Table 1). Median progression-free survival (PFS) was 35.0 months for D-Rd and 20.95 months for D-VMP (p = 0.72) (Figure 3A). At 3 years, survival (OS) was 60.0 % (95 % CI 36.2–99.5) in the D-Rd group (n = 10) and 62.5 % (42.8–91.4) in the D-VMP group (n = 16) (p = 0.49)(Figure 3B).

    Conclusions:   

    In a propensity-matched cohort of transplant-ineligible NDMM harboring del(17p13), D-Rd and D-VMP achieved comparable 3-year OS, with no significant PFS or OS differences. The numerically longer median PFS for D-Rd remains inconclusive given the small sample. Prospective trials in high-risk cytogenetic subsets are required to refine treatment choices in this vulnerable group.

    Acknowledge. This study, carried out under YODA Project #2025-0152, used data obtained from the Yale University Open Data Access Project, which has an agreement with JANSSEN RESEARCH & DEVELOPMENT, L.L.C. The interpretation and reporting of research using this data are solely the responsibility of the authors and do not necessarily represent the official views of the Yale University Open Data Access Project or JANSSEN RESEARCH & DEVELOPMENT, L.L.C. The original proposal can be found: https://yoda.yale.edu/data-request/2025-0152/.”