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S. Bringhen et al.
amethasone (KCyd) as initial treatment for transplant- ineligible NDMM patients.6,7 In both trials, KCyd was shown to be a safe and effective option for NDMM patients. Here we report the results of a pooled analysis of these two studies.
Methods
Study design and participants
For this analysis, we pooled together data from two phase I/II (IST-CAR-561; clinicaltrials.gov identifier: 01857115) and phase II (IST-CAR 506; clinicaltrials.gov identifier: 01346787) studies; these studies were led by the same co-operative groups. Patients were recruited from 14 sites across Italy (hospitals, clinics, oncology or medical centers). Both trials enrolled NDMM patients older than 65 years of age or younger but not eligible for autologous stem-cell transplantation. Inclusion and exclusion criteria are similar between the two source studies and have been previously pub- lished.6,7 Ethics committees or institutional review boards at the
study sites approved both studies, which were carried out in accordance with the Declaration of Helsinki. All patients provided written informed consent.
Procedures
In both studies, patients received nine 4-week induction cycles with carfilzomib, cyclophosphamide (orally, 300 mg on days 1, 8 and 15) and dexamethasone (40 mg on days 1, 8, 15 and 22). In the IST-CAR 561 study, patients received once-weekly carfilzomib at the dose of 70 mg/m2 (on days 1, 8 and 15), while in the IST-CAR 506 study patients received twice-weekly carfilzomib at the dose of 36 mg/m2 (on days 1, 2, 8, 9, 15 and 16). After the induction phase, patients received maintenance treatment with carfilzomib as single agent, which was administered at the same dose and schedule of the induction phase and until progressive disease or intolerable toxicity. Details of study procedures have been previ- ously published.6,7
Outcomes
Focusing on patients who received once- versus twice-weekly
Figure 1. Analysis profile. N: number; AE: adverse events; PD: pro- gressive disease; SPM: second primary malignancy.
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