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

• Type of Material: Article
• Authors: Douglas W Sborov, University of Utah; Muhamed Baljevic, Vanderbilt University; Brandi Reeves, University of North Carolina; Jacob Laubach, Dana Farber Cancer Institute; Yvonne A Efebera, OhioHealth; Cesar Rodriguez, Wake Forest University; Luciano J Costa, University of Alabama Birmingham; Ajai Chari, Mount Sinai School of Medicine; Rebecca Silbermann, Oregon Health and Science University; Sarah A Holstein, University of Nebraska Omaha; Larry D Anderson, UT Southwestern Medical Center; Jonathan Kaufman, Emory University; Nina Shah, University of California San Francisco; Huiling Pei, Janssen Research & Development, LLC; Sharmila Patel, Janssen Scientific Affairs, LLC; Annelore Cortoos, Janssen Scientific Affairs, LLC; Blake J Bartlett, Janssen Research & Development, LLC; Jessica Vermeulen, Janssen Research & Development, LLC; Thomas S Lin, Janssen Scientific Affairs, LLC; Peter M Voorhees, Atrium Health; Paul G Richardson, Dana‐Farber Cancer Institute
• Language: English
• Date: 2022-09-16
• Publisher: WILEY
• Publication Version: Final Published Version
• Copyright Statement: © 2022 Janssen Scientific Affairs, LLC. British Journal of Haematology published by British Society for Haematology and John Wiley & Sons Ltd.
• License: Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1111/bjh.18432
• Title of Journal or Parent Work: BRITISH JOURNAL OF HAEMATOLOGY
• Volume: 199
• Issue: 3
• Start Page: 355
• End Page: 365
• Keywords: vascular thromboembolic events; THROMBOEMBOLISM; ANTIBODY DARATUMUMAB; THALIDOMIDE; prophylaxis; Life Sciences & Biomedicine; VTEs; GRIFFIN; CRITERIA; daratumumab; newly diagnosed multiple myeloma; Hematology; Science & Technology
• Research Categories: Health Sciences, Oncology

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.