Efficacy and safety of carfilzomib-lenalidomide-dexamethasone in newly diagnosed multiple myeloma: pooled analysis of four single-arm studies

Abstract

Pooled analyses of four single-arm phase 1 and 2 studies (NCT01816971, NCT02405364, NCT01029054, NCT01402284) investigated the clinical effectiveness of carfilzomib-lenalidomide-dexamethasone (KRd) in newly diagnosed multiple myeloma (NDMM). Patients who did (Cohort 1; n = 122) and did not (Cohort 2; n = 99) undergo autologous stem cell transplant (high-dose melphalan [HDM]-ASCT) were included. Patients received a 28-day cycle of induction KRd. The rate of very good partial response or better, the primary endpoint, was 93% in Cohort 1 and 90% in Cohort 2. Two-year progression-free survival and overall survival rates were 88% and 96% for Cohort 1, and 85% and 97% for Cohort 2. At least 90% of patients in each cohort reported ≥1 grade 3 or 4 treatment-emergent adverse events. Subgroup analyses by age, International Staging System stage, and cytogenetic risk were consistent with the overall population. KRd is an effective and tolerable treatment option for patients with NDMM regardless of HDM-ASCT eligibility.

Keywords:

• Proteasome inhibitors
• newly diagnosed multiple myeloma
• clinical trials

Acknowledgments

The authors thank Jesse Potash (Amgen Inc.) and Maryann T. Travaglini, PharmD and Erin P. O’Keefe, PhD (ICON, North Wales, PA, USA), whose work was funded by Amgen Inc., for medical writing assistance in the preparation of this manuscript. OL had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Disclosure statement

OL has received honoraria from and/or served as a member on the board of directors for Adaptive, Amgen, Celgene, Janssen, and Takeda and has served as a member of independent data monitoring committees for Merck and Theradex. DK, JJ, and DD have no financial disclosures. MR has received fees for consultancy from Celgene and travel fees, lecture fees, and research funding from Amgen, Celgene, Janssen, and Takeda. AA and TAK have no personal financial interests to declare. They are employees of Statistics Collaborative, Inc. (SCI), and SCI was paid on a time and materials basis for work performed for this publication. SCI collaborates with other companies that are developing products for multiple myeloma and is bound by NDAs for all collaborations. KI and IM are employees and stockholders of Amgen. AJJ serves as a consultant, received honoraria, and is a member of the board of directors or advisory committee for AbbVie, Amgen, BMS, Celgene, GSK, Janssen, KaryoPharm Therapeutics, Millennium, Sanofi, SkyLineDx, and Takeda.

Data availability statement

Qualified researchers may request data from Amgen clinical studies. Complete details are available at http://www.amgen.com/datasharing.

Additional information

Funding

The study was sponsored and funded by Amgen Inc. As authors, Amgen employees were involved in the design and conduct of the analysis; collection, management, analysis, and interpretation of the data; preparation, review, and approval of the manuscript; and decision to submit the manuscript for publication.