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

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

    OPTIMIZATION OF POST-AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANT (ASCT) MAINTENANCE THERAPY IN MULTIPLE MYELOMA (MM): ANALYSIS OF A SINGLE-CENTER'S RESULTS OVER THE LAST 5 YEARS

    (PA-412) Optimization of Post-autologous Hematopoietic Stem Cell Transplant (ASCT) Maintenance Therapy in Multiple Myeloma (MM): Analysis of a Single-center's Results over the Last 5 Years

    Thursday, September 18, 2025
    Introduction: In recent years, treatment for patients under 70 years with multiple myeloma (MM) has evolved toward a 4-drug immunochemotherapy regimen, followed by autologous stem cell transplantation (ASCT) and a maintenance therapy for at least 2 years, typically with lenalidomide (LEN) monotherapy. However, in cytogenetically high-risk (HR) MM or suboptimal responses, this approach may be insufficient. The phase III AURIGA study showed that maintenance with daratumumab (DARA) plus LEN in patients with measurable residual disease (MRD)-positive status after ASCT improved MRD negativity rates and prolonged progression-free survival (PFS) compared to LEN alone. The objetive is to analyze post-ASCT maintenance treatments administered to MM patients at our center, focusing on their impact, especially in cytogenetically HR MM.

    Methods:

    Retrospective, single-center observational study (HU Príncipe de Asturias) conducted from April 2020 to May 2025 on MM patients receiving post-ASCT maintenance therapy. Clinical and cytogenetic data, type of treatment and outcomes were collected.

    Results: 23 MM patients were included, with a median age of 58 years(IQR 48–68); 74% were male and 14 (61%) had cytogenetic HR features. Most patients (69.6%) received only one prior line of therapy (56.5% had not received DARA during induction).

    Maintenance therapies were: DARA-LEN (48%), DARA alone (30%) and LEN monotherapy (13%). 52% had completed maintenance and 78% showed no clinical or biochemical evidence of disease progression.

    Among the 19 patients who received DARA-LEN or DARA, 4(21%) experienced disease progression. Among patients (3) who received LEN monotherapy, 1 (33%) showed progression.

    In the HR subgroup who received induction without daratumumab (n=8), the maintenance regimen was DARA-LEN (62.5%), DARA (25%) and LEN (12.5%). Serial MRD evaluations on day +100 post-ASCT and after 1 or 2 years revealed: persistent MRD positivity (n=3), sustained MRD negativity (n=1), MRD negativity turning positive at 2 years (n=1) and incomplete follow-up data in 3 cases. 3 patients (37%) experienced disease progression(1 during maintenance and 2 after it), while 62.5% remained progression-free.

    Among HR patients who received daratumumab during induction (n=6), maintenance regimens were DARA (50%), DARA-LEN (33.3%), and LEN (16.7%). Only one had MRD positivity at day +100 and after 2 years, with evident clinical progression. In this subgroup, 66.6% had MRD negativity at day +100 post-ASCT, one had MRD negativity at 1 year and 5 patients (83.3%) remain progression-free.
    In summary, among patients receiving DARA-LEN or DARA maintenance the progression rate was 21% (17.6% in HR patients) compared to 33% in those receiving LEN monotherapy.

    Conclusions: Maintenance therapy with DARA (either alone or with LEN) appears effective with a lower progression rate compared to LEN monotherapy—even among cytogenetically HR patients. Our findings suggest that post-ASCT daratumumab remains beneficial even in previously exposed patients.