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Age-based subgroup analysis of CASTOR and POLLUX
mised eligibility for the study, and it is recognized that this is a limitation of many MM studies.30 However, differences in efficacy were still observed between the treatment groups. An additional limitation is that the study did not assess frailty. The IMWG frailty score system which is based on age, comorbidities, and functional status, can be used to predict survival and toxicity, making it a useful met- ric for determining feasibility of a treatment regimen and for clinical trial design.19 This metric was adopted after these studies were initiated.
In conclusion, the safety and efficacy of daratumumab in combination with Rd or Vd does not appear to be neg- atively impacted by age in patients studied in POLLUX and CASTOR, and is consistent with the overall study populations. This subgroup analysis supports the addition of daratumumab to standard-of-care regimens in patients with RRMM, regardless of age.
Acknowledgments
The authors thank the patients who participated in this study, the staff members at the study sites, the data and safety monitor- ing committee, and staff members who were involved in data col- lection and analyses.
Funding
These studies (ClinicalTrials.gov Identifiers: NCT02076009 and NCT02136134) were sponsored by Janssen Research & Development, LLC. The data sharing policy of Janssen Pharmaceutical Companies of Johnson & Johnson is available at https://www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at http://yoda.yale.edu.Editorial and medical writing support were provided by Kristin Runkle, PhD, of MedErgy, and were funded by Janssen Global Services, LLC.
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