| Autor: |
Dimopoulos, M.A. Oriol, A. Nahi, H. San-Miguel, J. Bahlis, N.J. Usmani, S.Z. Rabin, N. Orlowski, R.Z. Komarnicki, M. Suzuki, K. Plesner, T. Yoon, S.-S. Ben Yehuda, D. Richardson, P.G. Goldschmidt, H. Reece, D. Lisby, S. Khokhar, N.Z. O'Rourke, L. Chiu, C. Qin, X. Guckert, M. Ahmadi, T. Moreau, P. POLLUX Investigators |
| Jazyk: |
angličtina |
| Rok vydání: |
2016 |
| Popis: |
BACKGROUND: Daratumumab showed promising efficacy alone and with lenalidomide and dexamethasone in a phase 1-2 study involving patients with relapsed or refractory multiple myeloma. METHODS: In this phase 3 trial, we randomly assigned 569 patients with multiple myeloma who had received one or more previous lines of therapy to receive lenalidomide and dexamethasone either alone (control group) or in combination with daratumumab (daratumumab group). The primary end point was progression-free survival. RESULTS: At a median follow-up of 13.5 months in a protocol-specified interim analysis, 169 events of disease progression or death were observed (in 53 of 286 patients [18.5%] in the daratumumab group vs. 116 of 283 [41.0%] in the control group; hazard ratio, 0.37; 95% confidence interval [CI], 0.27 to 0.52; P |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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