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037 _ _ |a DKFZ-2017-03074
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082 _ _ |a 610
100 1 _ |a Mai, E. K.
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245 _ _ |a Phase III trial of bortezomib, cyclophosphamide and dexamethasone (VCD) versus bortezomib, doxorubicin and dexamethasone (PAd) in newly diagnosed myeloma.
260 _ _ |a Basingstoke
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336 7 _ |a article
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520 _ _ |a We aimed at demonstrating non-inferiority of bortezomib/cyclophosphamide/dexamethasone (VCD) compared to bortezomib/doxorubicin/dexamethasone (PAd) induction therapy with respect to very good partial response rates or better (⩾VGPR) in 504 newly diagnosed, transplant-eligible multiple myeloma patients. VCD was found to be non-inferior to PAd with respect to ⩾VGPR rates (37.0 versus 34.3%, P=0.001). The rates of progressive disease (PD) were 0.4% (VCD) versus 4.8% (PAd; P=0.003). In the PAd arm, 11 of 12 patients with PD had either renal impairment (creatinine ⩾2 mg/dl) at diagnosis or the cytogenetic abnormality gain 1q21, whereas no PD was observed in these subgroups in the VCD arm. Leukocytopenia/neutropenia (⩾3°) occurred more frequently in the VCD arm (35.2% versus 11.3%, P<0.001). Neuropathy rates (⩾2°) were higher in the PAd group (14.9 versus 8.4%, P=0.03). Serious adverse events, both overall and those related to thromboembolic events, were higher in the PAd group (32.7 versus 24.0%, P=0.04 and 2.8 versus 0.4%, P=0.04). Stem cell collection was not impeded by VCD. VCD is as effective as PAd in terms of achieving ⩾VGPR rates with fewer PD and has a favorable toxicity profile. Therefore, VCD is preferable to PAd as induction therapy.
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650 _ 7 |a Boronic Acids
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650 _ 7 |a Pyrazines
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650 _ 7 |a Bortezomib
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650 _ 7 |a Dexamethasone
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650 _ 7 |a Doxorubicin
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650 _ 7 |a Cyclophosphamide
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700 1 _ |a Bertsch, U.
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700 1 _ |a Dürig, J.
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700 1 _ |a Kunz, C.
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700 1 _ |a Haenel, M.
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700 1 _ |a Blau, I. W.
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700 1 _ |a Munder, M.
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700 1 _ |a Jauch, A.
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700 1 _ |a Schurich, B.
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700 1 _ |a Hielscher, T.
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700 1 _ |a Merz, M.
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700 1 _ |a Huegle-Doerr, B.
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700 1 _ |a Seckinger, A.
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700 1 _ |a Hose, D.
|b 13
700 1 _ |a Hillengass, J.
|b 14
700 1 _ |a Raab, M. S.
|b 15
700 1 _ |a Neben, K.
|b 16
700 1 _ |a Lindemann, H-W
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700 1 _ |a Zeis, M.
|b 18
700 1 _ |a Gerecke, C.
|b 19
700 1 _ |a Schmidt-Wolf, I. G. H.
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700 1 _ |a Weisel, K.
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700 1 _ |a Scheid, C.
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700 1 _ |a Salwender, H.
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700 1 _ |a Goldschmidt, H.
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773 _ _ |a 10.1038/leu.2015.80
|g Vol. 29, no. 8, p. 1721 - 1729
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