Daratumumab plus CyBorD for patients with newly diagnosed AL amyloidosis: safety run-in results of ANDROMEDA
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- Giovanni Palladini
- Amyloidosis Research and Treatment Center, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Policlinico San Matteo, Pavia, Italy;
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- Efstathios Kastritis
- Department of Clinical Therapeutics, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece;
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- Mathew S. Maurer
- Columbia University Irving Medical Center, New York, NY;
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- Jeffrey Zonder
- Barbara Ann Karmanos Cancer Institute, Detroit, MI;
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- Monique C. Minnema
- Department of Hematology, University Medical Center Utrecht, Utrecht, The Netherlands;
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- Ashutosh D. Wechalekar
- Division of Medicine, Faculty of Medical Sciences, University College London, London, United Kingdom;
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- Arnaud Jaccard
- Centre Hospitalier Universitaire and Reference Center for AL Amyloidosis, Limoges, France;
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- Hans C. Lee
- Division of Cancer Medicine, Department of Lymphoma and Myeloma, The University of Texas MD Anderson Cancer Center, Houston, TX;
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- Naresh Bumma
- Division of Hematology, The Ohio State University Comprehensive Cancer Center, Columbus, OH;
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- Jonathan L. Kaufman
- Winship Cancer Institute, Emory University, Atlanta, GA;
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- Eva Medvedova
- Oregon Health & Science University, Portland, OR;
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- Tibor Kovacsovics
- Division of Hematology and Hematologic Malignancies, University of Utah School of Medicine, and the Huntsman Cancer Institute, Salt Lake City, UT;
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- Michael Rosenzweig
- Department of Hematology and Hematopoietic Cell Transplantation, Judy and Bernard Briskin Center for Multiple Myeloma Research, City of Hope, Duarte, CA;
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- Vaishali Sanchorawala
- Department of Medicine and Amyloidosis Center, Boston University School of Medicine and Boston Medical Center, Boston, MA;
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- Xiang Qin
- Janssen Research & Development, LLC, Spring House, PA;
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- Sandra Y. Vasey
- Janssen Research & Development, LLC, Spring House, PA;
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- Brendan M. Weiss
- Janssen Research & Development, LLC, Spring House, PA;
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- Jessica Vermeulen
- Janssen Research & Development, Leiden, The Netherlands; and
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- Giampaolo Merlini
- Amyloidosis Research and Treatment Center, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Policlinico San Matteo, Pavia, Italy;
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- Raymond L. Comenzo
- Division of Hematology/Oncology, John C. Davis Myeloma and Amyloid Program, Tufts Medical Center, Boston, MA
抄録
<jats:title>Abstract</jats:title> <jats:p>Although no therapies are approved for light chain (AL) amyloidosis, cyclophosphamide, bortezomib, and dexamethasone (CyBorD) is considered standard of care. Based on outcomes of daratumumab in multiple myeloma (MM), the phase 3 ANDROMEDA study (NCT03201965) is evaluating daratumumab-CyBorD vs CyBorD in newly diagnosed AL amyloidosis. We report results of the 28-patient safety run-in. Patients received subcutaneous daratumumab (DARA SC) weekly in cycles 1 to 2, every 2 weeks in cycles 3 to 6, and every 4 weeks thereafter for up to 2 years. CyBorD was given weekly for 6 cycles. Patients had a median of 2 involved organs (kidney, 68%; cardiac, 61%). Patients received a median of 16 (range, 1-23) treatment cycles. Treatment-emergent adverse events were consistent with DARA SC in MM and CyBorD. Infusion-related reactions occurred in 1 patient (grade 1). No grade 5 treatment-emergent adverse events occurred; 5 patients died, including 3 after transplant. Overall hematologic response rate was 96%, with a complete hematologic response in 15 (54%) patients; at least partial response occurred in 20, 22, and 17 patients at 1, 3, and 6 months, respectively. Renal response occurred in 6 of 16, 7 of 15, and 10 of 15 patients, and cardiac response occurred in 6 of 16, 6 of 13, and 8 of 13 patients at 3, 6, and 12 months, respectively. Hepatic response occurred in 2 of 3 patients at 12 months. Daratumumab-CyBorD was well tolerated, with no new safety concerns versus the intravenous formulation, and demonstrated robust hematologic and organ responses. This trial was registered at www.clinicaltrials.gov as #NCT03201965.</jats:p>
収録刊行物
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- Blood
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Blood 136 (1), 71-80, 2020-07-02
American Society of Hematology