INTRODUCTION: Two phase 3 studies demonstrated superior efficacy of intravenous daratumumab (DARA IV) plus bortezomib/melphalan/prednisone (ALCYONE) or lenalidomide/dexamethasone (Rd; MAIA) versus standard-of-care regimens for transplant-ineligible newly diagnosed multiple myeloma. In these studies, patients could switch from DARA IV to subcutaneous daratumumab (DARA SC) while receiving daratumumab monotherapy in ALCYONE (as of Cycle 11) or daratumumab plus Rd in MAIA. The phase 3 COLUMBA study demonstrated noninferiority of DARA SC to DARA IV. DARA SC reduced administration time, allowing patients to spend less time in healthcare settings, a relevant practical consideration for patient care in the COVID-19 pandemic/settings of limited healthcare resources. METHODS: DARA SC 1800 mg was administered every 4 weeks, per approved dosing schedules. We evaluated safety and patient-reported experience (ALCYONE only) among patients who switched from DARA IV to DARA SC. RESULTS: Fifty-seven patients in ALCYONE and 135 in MAIA switched to DARA SC. Three (2.2%; MAIA) patients reported injection-site reactions, all of which were mild. No infusion-related reactions occurred with DARA SC. In ALCYONE, >80% of patients preferred DARA SC over DARA IV. Grade 3/4 treatment-emergent adverse events (TEAEs) occurred in 5.3% of patients in ALCYONE and 25.9% in MAIA; one (0.7%; MAIA) patient experienced a TEAE with an outcome of death. CONCLUSION: For transplant-ineligible newly diagnosed multiple myeloma, DARA SC (monotherapy/with Rd) was safe and preferred over DARA IV. ClinicalTrials.gov, NCT02195479/NCT02252172.

Clinical Department of Haematology 1st Medical Department Charles University Prague Prague Czech Republic

Dalhousie University and Queen Elizabeth 2 Health Sciences Centre Halifax NS Canada

Department of Hematology Ankara University Ankara Turkey

Hôpital Andre Mignot Service d'Hematologie et d'Oncologie Le Chesnay France

Janssen Global Services Raritan NJ USA

Janssen Research and Development Beerse Belgium

Janssen Research and Development Leiden The Netherlands

Janssen Research and Development LLC Raritan NJ USA

Janssen Research and Development LLC Spring House PA USA

Janssen Research and Development LLC Titusville NJ USA

Leeds Cancer Centre Leeds Teaching Hospitals NHS Trust and University of Leeds Leeds UK

Royal Wolverhampton Hospitals NHS Trust and University Wolverhampton UK

University Hospital of Salamanca IBSAL Cancer Research Center IBMCC Salamanca Spain

Uniwersytet Medyczny we Wrocławiu Wroclaw Poland

UZ Brussel VUB Brussels Belgium

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$a Switching to daratumumab SC from IV is safe and preferred by patients with multiple myeloma / $c MV. Mateos, S. Rigaudeau, S. Basu, I. Spicka, R. Schots, T. Wrobel, G. Cook, M. Beksac, KS. Gries, A. Kudva, B. Tromp, R. Van Rampelbergh, H. Pei, S. Wroblewski, R. Carson, M. Delioukina, D. White

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$a INTRODUCTION: Two phase 3 studies demonstrated superior efficacy of intravenous daratumumab (DARA IV) plus bortezomib/melphalan/prednisone (ALCYONE) or lenalidomide/dexamethasone (Rd; MAIA) versus standard-of-care regimens for transplant-ineligible newly diagnosed multiple myeloma. In these studies, patients could switch from DARA IV to subcutaneous daratumumab (DARA SC) while receiving daratumumab monotherapy in ALCYONE (as of Cycle 11) or daratumumab plus Rd in MAIA. The phase 3 COLUMBA study demonstrated noninferiority of DARA SC to DARA IV. DARA SC reduced administration time, allowing patients to spend less time in healthcare settings, a relevant practical consideration for patient care in the COVID-19 pandemic/settings of limited healthcare resources. METHODS: DARA SC 1800 mg was administered every 4 weeks, per approved dosing schedules. We evaluated safety and patient-reported experience (ALCYONE only) among patients who switched from DARA IV to DARA SC. RESULTS: Fifty-seven patients in ALCYONE and 135 in MAIA switched to DARA SC. Three (2.2%; MAIA) patients reported injection-site reactions, all of which were mild. No infusion-related reactions occurred with DARA SC. In ALCYONE, >80% of patients preferred DARA SC over DARA IV. Grade 3/4 treatment-emergent adverse events (TEAEs) occurred in 5.3% of patients in ALCYONE and 25.9% in MAIA; one (0.7%; MAIA) patient experienced a TEAE with an outcome of death. CONCLUSION: For transplant-ineligible newly diagnosed multiple myeloma, DARA SC (monotherapy/with Rd) was safe and preferred over DARA IV. ClinicalTrials.gov, NCT02195479/NCT02252172.

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$a Spicka, Ivan $u Clinical Department of Haematology, 1st Medical Department, Charles University in Prague, Prague, Czech Republic

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$a Schots, Rik $u UZ Brussel-VUB, Brussels, Belgium

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$a Wrobel, Tomasz $u Uniwersytet Medyczny we Wrocławiu, Wroclaw, Poland

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$a Cook, Gordon $u Leeds Cancer Centre, Leeds Teaching Hospitals NHS Trust and University of Leeds, Leeds, UK

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$a Beksac, Meral $u Department of Hematology, Ankara University, Ankara, Turkey

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$a Gries, Katharine S $u Janssen Global Services, Raritan, NJ, USA

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$a Tromp, Brenda $u Janssen Research & Development, Leiden, The Netherlands

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$a Van Rampelbergh, Rian $u Janssen Research & Development, Beerse, Belgium

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