Daratumumab plus lenalidomide and dexamethasone versus lenalidomide and dexamethasone in relapsed or refractory multiple myeloma: Updated analysis of POLLUX

Meletios A. Dimopoulos, Jesus San-Miguel, Andrew Belch, Darrell White, Lotfi Benboubker, Gordon Cook, Merav Leiba, James Morton, P. Joy Ho, Kihyun Kim, Naoki Takezako, Philippe Moreau, Jonathan L. Kaufman, Heather J. Sutherland, Marc Lalancette, Hila Magen, Shinsuke Iida, Jin Seok Kim, H. Miles Prince, Tara CochraneAlbert Oriol, Nizar J. Bahlis, Ajai Chari, Lisa O’Rourke, Kaida Wu, Jordan M. Schecter, Tineke Casneuf, Christopher Chiu, David Soong, A. Kate Sasser, Nushmia Z. Khokhar, Hervé Avet-Loiseau, Saad Z. Usmani

Research output: Contribution to journalArticlepeer-review

126 Citations (Scopus)


In the POLLUX study, daratumumab plus lenalidomide/dexamethasone significantly reduced risk of progression/death versus lenalidomide/ dexamethasone alone in relapsed/refractory multiple myeloma. We provide one additional year of follow up and include the effect on minimal residual disease and in clinically relevant subgroups. After 25.4 months of follow up, daratumumab plus lenalidomide/dexamethasone prolonged progression-free survival versus lenalidomide/dexamethasone alone (median not reached vs. 17.5 months; hazard ratio, 0.41; 95% confidence interval, 0.31-0.53; P<0.0001). The overall response rate was 92.9% versus 76.4%, and 51.2% versus 21.0% achieved a complete response or better, respectively (both P<0.0001). At the 10–5 sensitivity threshold, 26.2% versus 6.4% were minimal residual disease–negative, respectively (P<0.0001). Post hoc analyses of clinically relevant patient subgroups demonstrated that progression-free survival was significantly prolonged for daratumumab plus lenalidomide/dexamethasone versus lenalidomide/dexamethasone regardless of number of prior lines of therapy. Patients previously treated with lenalidomide or thalidomide and those refractory to bortezomib received similar benefits (all P<0.01). Treatment benefit with daratumumab plus lenalidomide/dexamethasone was maintained in high-risk patients (median progression-free survival 22.6 vs. 10.2 months; hazard ratio, 0.53; 95% confidence interval, 0.25-1.13; P=0.0921) and patients with treatment-free intervals of >12 and ≤12 months and >6 and ≤6 months. No new safety signals were observed. In relapsed/refractory multiple myeloma patients, daratumumab plus lenalidomide/dexamethasone continued to improve progression-free survival and deepen responses versus lenalidomide/dexamethasone.

Original languageEnglish
Pages (from-to)2088-2096
Number of pages9
Issue number12
Publication statusPublished - 2018 Nov 30

Bibliographical note

Funding Information:
This study was 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. JLK consulted for BMS, Janssen, Celgene, Karyopharm, and Pharmacyclics.

Publisher Copyright:
© 2018 Ferrata Storti Foundation.

All Science Journal Classification (ASJC) codes

  • Hematology


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