Page 215 - Haematologica Vol. 109 - July 2024

ARTICLE - Plasma Cell Disorders
Carfilzomib, thalidomide, and dexamethasone are safe and effective in relapsed and/or refractory multiple myeloma: final report of the single-arm, multicenter, phase II ALLG MM018/AMN002 study
Slavisa Ninkovic,1,2 Simon J. Harrison,3,4 Je-Jung Lee,5,6 Nick Murphy,7 Jae Hoon Lee,8 Jane Estell,9 Vivien M. Chen,9,10 Noemi Horvath,11 Kihuyn Kim,12 Richard Eek,13 Bradley Augustson,14 Soo-Mee Bang,15 Shang-Yi Huang,16 Rajeev Rajagopal,17 Ferenc Szabo,18 Daniel Engeler,19 Belinda E. Butcher,20,21 Peter Mollee,22,23 Brian Durie,24 Wee Joo Chng25# and Hang Quach1,2#
1Department of Hematology, St. Vincent’s Hospital Melbourne, Melbourne, Australia; 2Faculty of Medicine, University of Melbourne, St. Vincent’s Hospital Melbourne, Melbourne, Australia; 3Department of Hematology, Peter MacCallum Cancer Center and Royal Melbourne Hospital, Melbourne, Australia; 4Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Australia; 5Department of Hematology-Oncology, Chonnam National University Hwasun Hospital, Hwasun, South Korea; 6Chonnam National University Medical School, Hwasun, South Korea; 7Department of Hematology, The Royal Hobart Hospital, Hobart, Australia; 8Department of Hematology, Gachon University Gil Medical Center, Incheon, South Korea; 9Department of Hematology, Concord Repatriation General Hospital, Concord, Australia; 10Faculty of Medicine and Health, University of Sydney, Sydney, Australia; 11Department of Hematology, Royal Adelaide Hospital, Adelaide, Australia; 12School of Medicine, Samsung Medical Center, Seoul, South Korea; 13Border Medical Oncology Research Unit, Albury Wodonga Regional Cancer Center, Albury, Australia; 14Hematology Cancer Care, Sir Charles Gairdner Hospital, Perth, Australia; 15Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea; 16Department of Medicine, National Taiwan University, Taipei, Taiwan; 17Department of Hematology, Middlemore Hospital, Auckland, New Zealand; 18Department of Hematology, Royal Darwin Hospital, Darwin, Australia; 19Australian Leukemia and Lymphoma Group, Melbourne, Australia; 20Biostatistics and Medical Writing, WriteSource Medical Pty Ltd, Sydney, Australia; 21School of Biomedical Sciences, University of New South Wales, Sydney, Australia; 22Department of Hematology, Princess Alexandra Hospital, Brisbane, Australia; 23School of Medicine, University of Queensland, Brisbane, Australia; 24Samuel Oschin Comprehensive Cancer Institute, Cedars- Sinai Outpatient Cancer Center, Los Angeles, CA, USA and 25Department of Hematology- Oncology, National University Cancer Institute, Singapore, Singapore
#WJC and HQ contributed equally as senior authors.
Abstract
This multicenter, phase II study of the Australasian Lymphoma and Leukemia Group and the Asian Myeloma Network inves- tigated fixed-duration (18-month) treatment with carfilzomib (K), thalidomide (T), and dexamethasone (d) (KTd) in patients with relapsed and/or refractory multiple myeloma who had received one to three prior lines of therapy. Patients received induction with up to 12 28-day cycles of carfilzomib (20 mg/m2 intravenously in cycle 1 on days 1 and 2, then 56 mg/m2 [36 mg/m2 for patients ≥75 years] from day 8 onwards), thalidomide 100 mg orally in the evening and weekly dexamethasone 40 mg (20 mg for patients ≥75 years). During maintenance, thalidomide was omitted, while carfilzomib was continued on days 1, 2, 15, and 16 with fortnightly dexamethasone. The primary endpoint was progression-free survival. Secondary endpoints were overall response rate, overall survival, duration of response, safety, and tolerability. Ninety-three patients (median age 66.3 years [range, 41.9-84.5]) were enrolled and followed up for a median of 26.4 months (range, 1.6-54.6). The median pro-
Haematologica | 109 July 2024
Correspondence: H. Quach hang.quach@svha.org.au
Received: Accepted: Early view:
September 19, 2023. January 5, 2024. January 18, 2024.
https://doi.org/10.3324/haematol.2023.284238
©2024 Ferrata Storti Foundation Published under a CC BY-NC license
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