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Leukemia. 2015 Aug;29(8):1721-9. doi: 10.1038/leu.2015.80. Epub 2015 Mar 19.

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

Author information

1
Department of Internal Medicine V, University Hospital Heidelberg and National Center for Tumor Diseases (NCT) Heidelberg on behalf of the German-Speaking Myeloma Multicenter Group (GMMG), Heidelberg, Germany.
2
Department of Hematology, University Hospital Essen, Essen, Germany.
3
Division of Biostatistics, German Cancer Research Center (DKFZ) Heidelberg, Heidelberg, Germany.
4
Department of Internal Medicine III, Klinikum Chemnitz, Chemnitz, Germany.
5
Medical Clinic, Charité University Medicine Berlin, Berlin, Germany.
6
Department of Internal Medicine III, University Medical Center Mainz, Mainz, Germany.
7
Institute of Human Genetics, University of Heidelberg, Heidelberg, Germany.
8
Coordination Centers for Clinical Trials (KKS), University Hospital Heidelberg, Heidelberg, Germany.
9
Department of Internal Medicine V, University Hospital Heidelberg, Heidelberg, Germany.
10
Department of Hematology and Oncology, Katholisches Krankenhaus Hagen, Hagen, Germany.
11
Department of Hematology, Asklepios Hospital St. Georg Hamburg, Hamburg, Germany.
12
Department of Hematology and Oncology, Helios Hospital Berlin Buch, Berlin, Germany.
13
Center for Integrated Oncology, University Hospital Bonn, Bonn, Germany.
14
Department of Hematology, Oncology and Immunology, University Hospital Tübingen, Tübingen, Germany.
15
Department of Internal Medicine I, University Hospital Köln, Köln, Germany.
16
Department of Hematology and Oncology, Asklepios Hospital Hamburg Altona, Hamburg, Germany.

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.

PMID:
25787915
DOI:
10.1038/leu.2015.80
[Indexed for MEDLINE]

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