Daratumumab plus lenalidomide, bortezomib and dexamethasone in newly diagnosed multiple myeloma: Analysis of vascular thrombotic events in the GRIFFIN study.

Autor: Sborov DW; Huntsman Cancer Institute, University of Utah School of Medicine, Salt Lake City, Utah, USA., Baljevic M; Division of Oncology & Hematology, Department of Internal Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA., Reeves B; University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA., Laubach J; Dana-Farber Cancer Institute, Boston, Massachusetts, USA., Efebera YA; OhioHealth, Columbus, Ohio, USA., Rodriguez C; Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA., Costa LJ; University of Alabama at Birmingham, Birmingham, Alabama, USA., Chari A; Tisch Cancer Institute, Mount Sinai School of Medicine, New York, New York, USA., Silbermann R; Knight Cancer Institute, Oregon Health & Science University, Portland, Oregon, USA., Holstein SA; Divison of Oncology & Hematology, Department of Internal Medicine, University of Nebraska Medical Center, Omaha, Nebraska, USA., Anderson LD Jr; Simmons Comprehensive Cancer Center, UT Southwestern Medical Center, Dallas, Texas, USA., Kaufman JL; Winship Cancer Institute, Emory University, Atlanta, Georgia, USA., Shah N; Department of Medicine, University of California San Francisco, San Francisco, California, USA., Pei H; Janssen Research & Development, LLC, Titusville, New Jersey, USA., Patel S; Janssen Scientific Affairs, LLC, Horsham, Pennsylvania, USA., Cortoos A; Janssen Scientific Affairs, LLC, Horsham, Pennsylvania, USA., Bartlett JB; Janssen Research & Development, LLC, Raritan, New Jersey, USA., Vermeulen J; Janssen Research & Development, LLC, Leiden, The Netherlands., Lin TS; Janssen Scientific Affairs, LLC, Horsham, Pennsylvania, USA., Voorhees PM; Levine Cancer Institute, Atrium Health, Charlotte, North Carolina, USA., Richardson PG; Dana-Farber Cancer Institute, Boston, Massachusetts, USA.
Jazyk: angličtina
Zdroj: British journal of haematology [Br J Haematol] 2022 Nov; Vol. 199 (3), pp. 355-365. Date of Electronic Publication: 2022 Sep 16.
DOI: 10.1111/bjh.18432
Abstrakt: Patients with multiple myeloma are at increased risk of vascular thromboembolic events (VTEs). This post hoc analysis evaluated VTEs in the randomised phase 2 GRIFFIN study (ClinicalTrials.gov Identifier: NCT02874742) that investigated lenalidomide/bortezomib/dexamethasone (RVd) ± daratumumab (D). Patients with newly diagnosed multiple myeloma who were eligible for autologous stem cell transplantation (ASCT) received D-RVd/RVd induction, high-dose therapy and ASCT, D-RVd/RVd consolidation and up to 2 years of lenalidomide maintenance therapy ± D. VTE prophylaxis was recommended (at least aspirin, ≥162 mg daily) in accordance with International Myeloma Working Group guidelines. In the safety population (D-RVd, n = 99; RVd, n = 102), VTEs occurred in 10.1% of D-RVd patients and 15.7% of RVd patients; grade 2-4 VTEs occurred in 9.1% and 14.7%, respectively. Median time to the first onset of VTE was longer for D-RVd versus RVd patients (305 days vs 119 days). Anti-thrombosis prophylaxis use was similar between arms (D-RVd, 84.8% vs RVd, 83.3%); among patients with VTEs, prophylaxis use at time of first VTE onset was 60.0% for D-RVd and 68.8% for RVd. In summary, the addition of daratumumab to RVd did not increase the incidence of VTEs, but the cumulative VTE incidence was relatively high in this cohort and anti-thrombotic prophylaxis use was suboptimal.
(© 2022 Janssen Scientific Affairs, LLC. British Journal of Haematology published by British Society for Haematology and John Wiley & Sons Ltd.)
Databáze: MEDLINE
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