Τίτλος:
Sustained minimal residual disease negativity in newly diagnosed multiple myeloma and the impact of daratumumab in MAIA and ALCYONE
Γλώσσες Τεκμηρίου:
Αγγλικά
Περίληψη:
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 at least 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 at least CR. In MAIA (D-Rd, n = 368; lenalidomide and dexamethasone [Rd], n = 369) and ALCYONE (D-VMP, n = 350; bortezomib/melphalan/prednisone [VMP], n = 356), the median duration of follow-up was 36.4 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 vs control groups. In a pooled analysis, patients who were MRD negative had improved PFS vs patients who were MRD positive. Patients with NDMM who achieved MRD-negative status or sustained MRD negativity had deep remission and improved clinical outcomes. These trials were registered at www.clinicaltrials.gov as #NCT02252172 (MAIA) and #NCT02195479 (ALCYONE). © 2022 American Society of Hematology
Συγγραφείς:
San-Miguel, J.
Avet-Loiseau, H.
Paiva, B.
Kumar, S.
Dimopoulos, M.A.
Facon, T.
Mateos, M.-V.
Touzeau, C.
Jakubowiak, A.
Usmani, S.Z.
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.
Qi, M.
Bahlis, N.J.
Περιοδικό:
Blood advances
Λέξεις-κλειδιά:
bortezomib; daratumumab; dexamethasone; lenalidomide; melphalan; prednisone; antineoplastic agent; daratumumab; monoclonal antibody, aged; Article; cancer control; cancer patient; cancer prognosis; cancer regression; cancer risk; cancer staging; cancer survival; clinical feature; clinical outcome; controlled study; demographics; disease exacerbation; drug efficacy; follow up; high throughput sequencing; human; intention to treat analysis; kidney function; major clinical study; minimal residual disease; mortality risk; multicenter study; multiple cycle treatment; multiple myeloma; open study; overall survival; phase 3 clinical trial; progression free survival; randomized controlled trial; risk assessment; time to treatment; treatment response; clinical trial; female; male; middle aged; minimal residual disease; multiple myeloma; treatment outcome, Aged; Antibodies, Monoclonal; Antineoplastic Combined Chemotherapy Protocols; Female; Humans; Male; Middle Aged; Multiple Myeloma; Neoplasm, Residual; Progression-Free Survival; Treatment Outcome
DOI:
10.1182/blood.2020010439
