Keywords:
COMBINATION
;
STEM-CELL TRANSPLANTATION
;
INDUCTION THERAPY
;
MAINTENANCE
;
THALIDOMIDE PLUS DEXAMETHASONE
;
Lenalidomide
;
PERIPHERAL NEUROPATHY
;
UNTREATED MULTIPLE-MYELOMA
;
HIGH RESPONSE RATES
;
RANDOMIZED PHASE-3
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 degrees) occurred more frequently in the VCD arm (35.2% versus 11.3%, P〈0.001). Neuropathy rates (〉= 2 degrees) 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.
Type of Publication:
Journal article published
Deep Link:
http://www.dkfz.de/cgi-bin/sel?http://www.dkfz.de/PublicationManager/Show/ShowJournal.aspx%3fpublishedId=59306
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