@article{e999220c815c49aebee136c4e2629286,
title = "Daratumumab plus lenalidomide, bortezomib and dexamethasone in newly diagnosed multiple myeloma: Analysis of vascular thrombotic events in the GRIFFIN study",
abstract = "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.",
keywords = "GRIFFIN, VTEs, daratumumab, newly diagnosed multiple myeloma, prophylaxis, vascular thromboembolic events",
author = "Sborov, {Douglas W.} and Muhamed Baljevic and Brandi Reeves and Jacob Laubach and Efebera, {Yvonne A.} and Cesar Rodriguez and Costa, {Luciano J.} and Ajai Chari and Rebecca Silbermann and Holstein, {Sarah A.} and Anderson, {Larry D.} and Kaufman, {Jonathan L.} and Nina Shah and Huiling Pei and Sharmila Patel and Annelore Cortoos and Bartlett, {J. Blake} and Jessica Vermeulen and Lin, {Thomas S.} and Voorhees, {Peter M.} and Richardson, {Paul G.}",
note = "Funding Information: Douglas W. Sborov acted as an advisor/consultant for Janssen, Bristol Myers Squibb/Celgene, Sanofi, AbbVie, and GlaxoSmithKline. Muhamed Baljevic acted as a consultant for Bristol Myers Squibb/Celgene; participated in advisory committees for Oncopeptides, Janssen, Karyopharm, and Bristol Myers Squibb/Celgene; and received research support from Amgen and Exelixis. Brandi Reeves acted as a consultant and received honoraria from Bristol Myers Squibb, Incyte, and Pharma Essentia. Jacob Laubach has nothing to disclose. Yvonne A. Efebera has received honoraria from Janssen, Takeda, GlaxoSmithKline, Oncopeptide and Sanofi; served on the speakers bureau and advisory board for Oncopeptide, Sanofi and GlaxoSmithKline; and has received research fund from Bristol Myers Squib. Cesar Rodriguez acted as an advisor and participated on speakers bureaus for Amgen, Bristol Myers Squibb, Takeda, Karyopharm, Oncopeptides, and Sanofi. Luciano J. Costa received research funding from Amgen and Janssen; and acted as a consultant for Amgen, Janssen, Bristol Myers Squibb, and Karyopharm. Ajai Chari participated in advisory committees for AbbVie, Amgen, Bristol Myers Squibb/Celgene, Genentech, GlaxoSmithKline, Janssen, Karyopharm, Oncopeptides, Sanofi, Seattle Genetics, Secura Bio, and Shattuck Labs; received research funding from Amgen, Bristol Myers Squibb/Celgene, Janssen, Seattle Genetics, and Takeda/Millennium; and acted as a consultant for Amgen, Antengene, Bristol Myers Squibb/Celgene, Janssen, Secura Bio, and Takeda/Millennium. Rebecca Silbermann acted as a consultant for Janssen and Sanofi Aventis; and received research funding from Sanofi Aventis. Sarah A. Holstein acted as a consultant for and received honoraria from Celgene, Genentech, GlaxoSmithKline, Janssen, Secura Bio, Sorrento, Takeda, and Oncopeptides; and received research funding from Oncopeptides. Larry D. Anderson participated in advisory committees and acted as a consultant for Amgen, Bristol Myers Squibb, Celgene, GlaxoSmithKline, Janssen, Karyopharm, Oncopeptides, AbbVie, and Prothena. Jonathan L. Kaufman participated in advisory committees for Incyte and TG Therapeutics; acted as a consultant for AbbVie, Bristol Myers Squibb, Janssen, Roche/Genentech, and Tecnopharma; received research funding from AbbVie, Amgen, Bristol Myers Squibb, Fortis Therapeutics, Heidelberg Pharma, Janssen, Novartis, Roche/Genentech, Sutro Biopharma, and Takeda; and received honoraria from AbbVie, Janssen, Roche/Genentech, and Tecnopharma. Nina Shah acted as a consultant for GlaxoSmithKline, Amgen, Indapta Therapeutics, Sanofi, Care Dx, Kite, Karyopharma, and Oncopeptides; and received research funding from Celgene/Bristol Myers Squibb, Janssen, Bluebird Bio, Sutro Biopharma, Teneobio, Poseida, and Nektar. Huiling Pei, Annelore Cortoos, J. Blake Bartlett and Jessica Vermeulen are current employees and stock shareholders of Janssen. Sharmila Patel is a current employee of Janssen. Thomas S. Lin is a current employee and stock shareholder of Janssen; and holds stock in GlaxoSmithKline. Peter M. Voorhees participated in advisory committees for AbbVie, Bristol Myers Squibb, GlaxoSmithKline, Janssen, Karyopharm, Oncopeptides, Pfizer, and Sanofi; and acted as a consultant for Bristol Myers Squibb, Novartis, Oncopeptides, and Secura Bio. Paul G. Richardson received institutional research support from Oncopeptides, Celgene/Bristol Myers Squibb, Takeda, and Karyopharm; and received honoraria for his role as an advisory committee member from Karyopharm, Oncopeptides, Celgene/Bristol Myers Squibb, Takeda, Janssen, Sanofi, Secura Bio, GlaxoSmithKline, Regeneron, AstraZeneca, and Protocol Intelligence. Funding Information: The authors thank the patients who volunteered to participate in this trial, their families, and the staff members at the trial sites who cared for them. This study ( ClinicalTrials.gov Identifier: NCT02874742) was supported by Janssen Oncology and designed in partnership with Alliance Foundation Trials ( https://acknowledgments.alliancefound.org ). Writing and editorial support were provided by Charlotte Majerczyk, PhD, and Michelle Kwon, PhD, of Cello Health Communications/MedErgy, and were funded by Janssen Pharmaceuticals. This study ( ClinicalTrials.gov Identifier: NCT02874742) was supported by research funding from Janssen Oncology. Publisher Copyright: {\textcopyright} 2022 Janssen Scientific Affairs, LLC. British Journal of Haematology published by British Society for Haematology and John Wiley & Sons Ltd.",
year = "2022",
month = nov,
doi = "10.1111/bjh.18432",
language = "English (US)",
volume = "199",
pages = "355--365",
journal = "British Journal of Haematology",
issn = "0007-1048",
publisher = "Wiley-Blackwell",
number = "3",
}