Phase III trial of bortezomib, cyclophosphamide and dexamethasone in newly diagnosed myeloma
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 pati...
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| creator | Mai, E.K Bertsch, U Durig, J Kunz, C Haenel, M Blau, I.W Munder, M Jauch, A Schurich, B Hielscher, T Merz, M Huegle-Doerr, B Seckinger, A Hose, D Hillengass, J Raab, M.S Neben, K Lindemann, H.-W Zeis, M Gerecke, C Schmidt-Wolf, I.G.H Weisel, K Scheid, C Salwender, H Goldschmidt, H |
| description | 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 ([greater than or equal to] 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. Leukemia (2015) 29, 1721-1729; doi:10.1038/leu.2015.80 |
| doi_str_mv | 10.1038/leu.2015.80 |
| format | Article |
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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 ([greater than or equal to] 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. Leukemia (2015) 29, 1721-1729; doi:10.1038/leu.2015.80</description><identifier>ISSN: 0887-6924</identifier><identifier>DOI: 10.1038/leu.2015.80</identifier><language>eng</language><publisher>Nature Publishing Group</publisher><subject>Comparative analysis ; Drug therapy ; Drug therapy, Combination ; Multiple myeloma ; Patient outcomes</subject><ispartof>Leukemia, 2015-08, p.1721</ispartof><rights>COPYRIGHT 2015 Nature Publishing Group</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids></links><search><creatorcontrib>Mai, E.K</creatorcontrib><creatorcontrib>Bertsch, U</creatorcontrib><creatorcontrib>Durig, J</creatorcontrib><creatorcontrib>Kunz, C</creatorcontrib><creatorcontrib>Haenel, M</creatorcontrib><creatorcontrib>Blau, I.W</creatorcontrib><creatorcontrib>Munder, M</creatorcontrib><creatorcontrib>Jauch, A</creatorcontrib><creatorcontrib>Schurich, B</creatorcontrib><creatorcontrib>Hielscher, T</creatorcontrib><creatorcontrib>Merz, M</creatorcontrib><creatorcontrib>Huegle-Doerr, B</creatorcontrib><creatorcontrib>Seckinger, A</creatorcontrib><creatorcontrib>Hose, D</creatorcontrib><creatorcontrib>Hillengass, J</creatorcontrib><creatorcontrib>Raab, M.S</creatorcontrib><creatorcontrib>Neben, K</creatorcontrib><creatorcontrib>Lindemann, H.-W</creatorcontrib><creatorcontrib>Zeis, M</creatorcontrib><creatorcontrib>Gerecke, C</creatorcontrib><creatorcontrib>Schmidt-Wolf, I.G.H</creatorcontrib><creatorcontrib>Weisel, K</creatorcontrib><creatorcontrib>Scheid, C</creatorcontrib><creatorcontrib>Salwender, H</creatorcontrib><creatorcontrib>Goldschmidt, H</creatorcontrib><title>Phase III trial of bortezomib, cyclophosphamide and dexamethasone in newly diagnosed myeloma</title><title>Leukemia</title><description>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 ([greater than or equal to] 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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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 ([greater than or equal to] 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. Leukemia (2015) 29, 1721-1729; doi:10.1038/leu.2015.80</abstract><pub>Nature Publishing Group</pub><doi>10.1038/leu.2015.80</doi></addata></record> |
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| subjects | Comparative analysis Drug therapy Drug therapy, Combination Multiple myeloma Patient outcomes |
| title | Phase III trial of bortezomib, cyclophosphamide and dexamethasone in newly diagnosed myeloma |
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