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    Daratumumab plus bortezomib, melphalan, and prednisone versus bortezomib, melphalan, and prednisone in transplant-ineligible newly diagnosed multiple myeloma: frailty subgroup analysis of ALCYONE

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    Author
    Garg, Mamta
    Keyword
    CD38
    frailty
    daratumumab
    bortezomib
    melphalan
    prednisone
    D-VMP
    multiple myeloma
    Date
    2021
    
    Metadata
    Show full item record
    Publisher's URL
    https://www.clinical-lymphoma-myeloma-leukemia.com/article/S2152-2650(21)00210-X/fulltext
    Abstract
    Background: In the phase 3 ALCYONE study, daratumumab plus bortezomib/melphalan/prednisone (D-VMP) versus bortezomib/melphalan/prednisone (VMP) significantly improved progression-free survival (PFS) and overall survival (OS) in transplant-ineligible, newly diagnosed multiple myeloma (NDMM) patients. We present a subgroup analysis of ALCYONE by patient frailty status. Patients and methods: Frailty assessment was performed retrospectively using age, Charlson comorbidity index, and baseline Eastern Cooperative Oncology Group performance status score. Patients were classified as fit (0), intermediate (1), or frail (≥2); a nonfrail category combined fit and intermediate patients. Results: Among randomized patients (D-VMP, n = 350; VMP, n = 356), 391 (55.4%) were nonfrail (D-VMP, 187 [53.4%]; VMP, 204 [57.3%]) and 315 (44.6%) were frail (163 [46.6%]; 152 [42.7%]). After 40.1-months median follow-up, nonfrail patients had longer PFS and OS than frail patients, but benefits of D-VMP versus VMP were maintained across subgroups: PFS nonfrail (median, 45.7 vs. 19.1 months; hazard ratio [HR], 0.36; P < .0001), frail (32.9 vs. 19.5 months; HR, 0.51; P < .0001); OS nonfrail (36-month rate, 83.6% vs. 74.5%), frail (71.4% vs. 59.0%). Improved greater than or equal to complete response and minimal residual disease (10-5)-negativity rates were observed for D-VMP versus VMP across subgroups. The 2 most common grade 3/4 treatment-emergent adverse events were neutropenia (nonfrail: 39.2% [D-VMP] and 42.4% [VMP]; frail: 41.3% and 34.4%) and thrombocytopenia (nonfrail: 32.8% and 36.9%; frail: 36.9% and 39.1%). Conclusion: Our findings support the clinical benefit of D-VMP in transplant-ineligible NDMM patients enrolled in ALCYONE, regardless of frailty status. Trial registration: ClinicalTrials.gov NCT02195479.
    Citation
    Mateos, M. V., Dimopoulos, M. A., Cavo, M., Suzuki, K., Knop, S., Doyen, C., Lucio, P., Nagy, Z., Pour, L., Grosicki, S., Crepaldi, A., Liberati, A. M., Campbell, P., Yoon, S. S., Iosava, G., Fujisaki, T., Garg, M., Iida, S., Bladé, J., Ukropec, J., … San-Miguel, J. (2021). Daratumumab Plus Bortezomib, Melphalan, and Prednisone Versus Bortezomib, Melphalan, and Prednisone in Transplant-Ineligible Newly Diagnosed Multiple Myeloma: Frailty Subgroup Analysis of ALCYONE. Clinical lymphoma, myeloma & leukemia, 21(11), 785–798. https://doi.org/10.1016/j.clml.2021.06.005
    Type
    Article
    URI
    http://hdl.handle.net/20.500.12904/15249
    Collections
    Haematology

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