Phase III trial of bortezomib, cyclophosphamide and dexamethasone (VCD) versus bortezomib, doxorubicin and dexamethasone (PAd) in newly diagnosed myeloma

E K Mai; U Bertsch; J Dürig; C Kunz; M Haenel; I W Blau; M Munder; A Jauch; B Schurich; T Hielscher; M Merz; B Huegle-Doerr; A Seckinger; D Hose; J Hillengass; M S Raab; K Neben; H-W Lindemann; M Zeis; C Gerecke; I G H Schmidt-Wolf; K Weisel; C Scheid; H Salwender; H Goldschmidt

doi:10.1038/leu.2015.80

Phase III trial of bortezomib, cyclophosphamide and dexamethasone (VCD) versus bortezomib, doxorubicin and dexamethasone (PAd) in newly diagnosed myeloma

Standard

Phase III trial of bortezomib, cyclophosphamide and dexamethasone (VCD) versus bortezomib, doxorubicin and dexamethasone (PAd) in newly diagnosed myeloma. / Mai, E K; Bertsch, U; Dürig, 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.

in: LEUKEMIA, Jahrgang 29, Nr. 8, 08.2015, S. 1721-9.

Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung

Harvard

Mai, EK, Bertsch, U, Dürig, J, Kunz, C, Haenel, M, Blau, IW, Munder, M, Jauch, A, Schurich, B, Hielscher, T, Merz, M, Huegle-Doerr, B, Seckinger, A, Hose, D, Hillengass, J, Raab, MS, Neben, K, Lindemann, H-W, Zeis, M, Gerecke, C, Schmidt-Wolf, IGH, Weisel, K, Scheid, C, Salwender, H & Goldschmidt, H 2015, 'Phase III trial of bortezomib, cyclophosphamide and dexamethasone (VCD) versus bortezomib, doxorubicin and dexamethasone (PAd) in newly diagnosed myeloma', LEUKEMIA, Jg. 29, Nr. 8, S. 1721-9. https://doi.org/10.1038/leu.2015.80

APA

Mai, E. K., Bertsch, U., Dürig, 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., ... Goldschmidt, H. (2015). Phase III trial of bortezomib, cyclophosphamide and dexamethasone (VCD) versus bortezomib, doxorubicin and dexamethasone (PAd) in newly diagnosed myeloma. LEUKEMIA, 29(8), 1721-9. https://doi.org/10.1038/leu.2015.80

Vancouver

Mai EK, Bertsch U, Dürig J, Kunz C, Haenel M, Blau IW et al. Phase III trial of bortezomib, cyclophosphamide and dexamethasone (VCD) versus bortezomib, doxorubicin and dexamethasone (PAd) in newly diagnosed myeloma. LEUKEMIA. 2015 Aug;29(8):1721-9. https://doi.org/10.1038/leu.2015.80

Bibtex

@article{dd9ee8198926405c9c645a6e1235c42e,

title = "Phase III trial of bortezomib, cyclophosphamide and dexamethasone (VCD) versus bortezomib, doxorubicin and dexamethasone (PAd) in newly diagnosed myeloma",

abstract = "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. ",

keywords = "Adult, Aged, Antineoplastic Combined Chemotherapy Protocols, Boronic Acids, Bortezomib, Cyclophosphamide, Dexamethasone, Doxorubicin, Female, Follow-Up Studies, Hematopoietic Stem Cell Mobilization, Humans, Induction Chemotherapy, Male, Middle Aged, Multiple Myeloma, Neoplasm Staging, Prognosis, Prospective Studies, Pyrazines, Remission Induction, Survival Rate, Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't",

author = "Mai, {E K} and U Bertsch and J D{\"u}rig and C Kunz and M Haenel and Blau, {I W} and M Munder and A Jauch and B Schurich and T Hielscher and M Merz and B Huegle-Doerr and A Seckinger and D Hose and J Hillengass and Raab, {M S} and K Neben and H-W Lindemann and M Zeis and C Gerecke and Schmidt-Wolf, {I G H} and K Weisel and C Scheid and H Salwender and H Goldschmidt",

year = "2015",

month = aug,

doi = "10.1038/leu.2015.80",

language = "English",

volume = "29",

pages = "1721--9",

journal = "LEUKEMIA",

issn = "0887-6924",

publisher = "NATURE PUBLISHING GROUP",

number = "8",

}

RIS

TY - JOUR

T1 - Phase III trial of bortezomib, cyclophosphamide and dexamethasone (VCD) versus bortezomib, doxorubicin and dexamethasone (PAd) in newly diagnosed myeloma

AU - Mai, E K

AU - Bertsch, U

AU - Dürig, J

AU - Kunz, C

AU - Haenel, M

AU - Blau, I W

AU - Munder, M

AU - Jauch, A

AU - Schurich, B

AU - Hielscher, T

AU - Merz, M

AU - Huegle-Doerr, B

AU - Seckinger, A

AU - Hose, D

AU - Hillengass, J

AU - Raab, M S

AU - Neben, K

AU - Lindemann, H-W

AU - Zeis, M

AU - Gerecke, C

AU - Schmidt-Wolf, I G H

AU - Weisel, K

AU - Scheid, C

AU - Salwender, H

AU - Goldschmidt, H

PY - 2015/8

Y1 - 2015/8

N2 - 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.

AB - 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.

KW - Adult

KW - Aged

KW - Antineoplastic Combined Chemotherapy Protocols

KW - Boronic Acids

KW - Bortezomib

KW - Cyclophosphamide

KW - Dexamethasone

KW - Doxorubicin

KW - Female

KW - Follow-Up Studies

KW - Hematopoietic Stem Cell Mobilization

KW - Humans

KW - Induction Chemotherapy

KW - Male

KW - Middle Aged

KW - Multiple Myeloma

KW - Neoplasm Staging

KW - Prognosis

KW - Prospective Studies

KW - Pyrazines

KW - Remission Induction

KW - Survival Rate

KW - Clinical Trial, Phase III

KW - Comparative Study

KW - Journal Article

KW - Multicenter Study

KW - Randomized Controlled Trial

KW - Research Support, Non-U.S. Gov't

U2 - 10.1038/leu.2015.80

DO - 10.1038/leu.2015.80

M3 - SCORING: Journal article

C2 - 25787915

VL - 29

SP - 1721

EP - 1729

JO - LEUKEMIA

JF - LEUKEMIA

SN - 0887-6924

IS - 8

ER -