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Daratumumab, bortezomib, cyclophosphamide and dexamethasone in newly diagnosed and relapsed multiple myeloma: LYRA study.


ABSTRACT: This United States community study evaluated the combination of daratumumab, bortezomib, cyclophosphamide and dexamethasone (D-VCd) in newly diagnosed multiple myeloma (NDMM) and relapsed multiple myeloma (RMM). Patients received 4-8 induction cycles of bortezomib 1·5 mg/m2 , cyclophosphamide 300 mg/m2 and dexamethasone 40 mg weekly. Intravenous daratumumab 16 mg/kg was administered as approved except for a split-first dose in Cycle 1. Eligible patients underwent autologous stem cell transplantation. All patients received ?12 daratumumab maintenance doses monthly. Eighty-six NDMM and 14 RMM patients received ?1 treatment dose. In NDMM patients, very good partial response or better (?VGPR) and overall response rates after 4 induction cycles were 44% (primary endpoint) and 79%, respectively, and 56% and 81% at end of induction. The 12-month progression-free survival (PFS) rate was 87%. Efficacy was also observed in RMM patients. Fatigue (59%) and neutropenia (13%) were the most frequent treatment-emergent adverse event (TEAE) and grade 3/4 TEAE, respectively. Infusion reactions occurred in 54% of patients, primarily during the first dose, and were mild (2% grade 3). The first 2 daratumumab infusions were 4·5 and 3·8 h (median). Overall, D-VCd was well tolerated, split-first daratumumab dosing was feasible, the ?VGPR rate after 4 cycles was 44% and the 1-year PFS rate was 87%.

SUBMITTER: Yimer H 

PROVIDER: S-EPMC6593455 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature

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Daratumumab, bortezomib, cyclophosphamide and dexamethasone in newly diagnosed and relapsed multiple myeloma: LYRA study.

Yimer Habte H   Melear Jason J   Faber Edward E   Bensinger William I WI   Burke John M JM   Narang Mohit M   Stevens Don D   Gunawardena Sriya S   Lutska Yana Y   Qi Keqin K   Ukropec Jon J   Qi Ming M   Lin Thomas S TS   Rifkin Robert M RM  

British journal of haematology 20190303 3


This United States community study evaluated the combination of daratumumab, bortezomib, cyclophosphamide and dexamethasone (D-VCd) in newly diagnosed multiple myeloma (NDMM) and relapsed multiple myeloma (RMM). Patients received 4-8 induction cycles of bortezomib 1·5 mg/m<sup>2</sup> , cyclophosphamide 300 mg/m<sup>2</sup> and dexamethasone 40 mg weekly. Intravenous daratumumab 16 mg/kg was administered as approved except for a split-first dose in Cycle 1. Eligible patients underwent autologous  ...[more]

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