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| # Sample Medical Document for Testing ResearchTeam | |
| ## Introduction | |
| **Daratumumab** is a human monoclonal antibody that targets CD38, a glycoprotein highly expressed on multiple myeloma cells. Clinical studies have demonstrated significant efficacy in treating relapsed and refractory multiple myeloma patients. | |
| ## Key Clinical Claims | |
| ### Primary Efficacy Findings | |
| The POLLUX study demonstrated that **daratumumab in combination with lenalidomide and dexamethasone significantly improved progression-free survival** compared to lenalidomide and dexamethasone alone (median not reached vs. 18.4 months; HR=0.37; 95% CI: 0.27-0.52; p<0.001).¹ | |
| In the CASTOR trial, **daratumumab plus bortezomib and dexamethasone showed superior overall response rates** of 83% versus 63% in the control arm (p<0.001).² | |
| ### Safety Profile | |
| **The most common adverse events observed were infusion-related reactions** occurring in approximately 48% of patients during the first infusion, with rates decreasing to less than 5% by the second infusion.³ | |
| ## Product Information | |
| This study was conducted across multiple countries including **Argentina, Brazil, Chile, and Mexico** for regulatory approval in Latin American markets. | |
| The content is provided in **Spanish** for healthcare professionals in these regions. | |
| ## References | |
| 1. Dimopoulos MA, Oriol A, Nopoka H, et al. Daratumumab, lenalidomide, and dexamethasone for multiple myeloma. N Engl J Med. 2016;375(14):1319-1331. | |
| 2. Palumbo A, Chanan-Khan A, Weisel K, et al. Daratumumab, bortezomib, and dexamethasone for multiple myeloma. N Engl J Med. 2016;375(8):754-766. | |
| 3. Safety data from pooled analysis of POLLUX and CASTOR studies. Presented at ASH 2016. | |
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| **Contact Information:** | |
| Janssen-Cilag Argentina S.A. | |
| Buenos Aires, Argentina | |
| Tel: +54-11-4732-5000 | |
| **Important Safety Information:** | |
| Please refer to full prescribing information for complete safety profile and contraindications. |