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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
Dimopoulos MA, Oriol A, Nopoka H, et al. Daratumumab, lenalidomide, and dexamethasone for multiple myeloma. N Engl J Med. 2016;375(14):1319-1331.
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.
Safety data from pooled analysis of POLLUX and CASTOR studies. Presented at ASH 2016.
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.