| Autor: |
San-Miguel, JF, Avet-Loiseau, H, Paiva, B, Kumar, SK, Dimopoulos, MAA, Facon, T, Mateos, M-V, Touzeau, C, Jakubowiak, AJ, Usmani, SZ, Cook, G, Cavo, M, Quach, H, Ukropec, J, Ramaswami, P, Pei, H, Qi, M, Sun, S, Wang, J, Krevvata, M, DeAngelis, N, Heuck, C, Van Rampelbergh, R, Kudva, A, Kobos, R, Bahlis, NJ |
| Jazyk: |
angličtina |
| Rok vydání: |
2022 |
| Předmět: |
|
| ISSN: |
0006-4971 |
| Popis: |
In patients with transplant-ineligible newly diagnosed multiple myeloma (NDMM), daratumumab reduced the risk of disease progression or death by 44% in MAIA (daratumumab/lenalidomide/dexamethasone; D-Rd) and 58% in ALCYONE (daratumumab/bortezomib/melphalan/prednisone; D-VMP). Minimal residual disease (MRD) is a sensitive measure of disease and response to therapy. MRD-negativity status and durability were assessed in MAIA and ALCYONE. MRD assessments using next-generation sequencing (10–5) occurred for patients achieving complete response (CR) or better, and after ≥CR at 12, 18, 24, and 30 months from the first dose. Progression-free survival (PFS) by MRD status and sustained MRD negativity lasting ≥6 and ≥12 months were analyzed in the intent-to-treat population and among patients achieving ≥CR. In MAIA, (D-Rd, n=368; Rd, n=369), and ALCYONE (D-VMP, n=350; VMP, n=356), the median duration of follow-up was 36.4 months and 40.1 months, respectively. MRD-negative status and sustained MRD negativity lasting ≥6 and ≥12 months were associated with improved PFS, regardless of treatment group. However, daratumumab-based therapy improved rates of MRD negativity lasting ≥6 months (D-Rd, 14.9% vs Rd, 4.3%; D-VMP, 15.7% vs VMP, 4.5%) and ≥12 months (D-Rd, 10.9% vs Rd, 2.4%; D-VMP, 14.0% vs VMP, 2.8%), both of which translated to improved PFS versus control groups. In a pooled analysis, patients who were MRD negative had improved PFS versus patients who were MRD positive. Patients with NDMM who achieved MRD-negative status or sustained MRD negativity had deep remission and improved clinical outcomes. ClinicalTrials.gov identifier NCT02252172 (MAIA); NCT02195479 (ALCYONE). |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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