A phase 2 trial of the efficacy and safety of elotuzumab in combination with pomalidomide, carfilzomib and dexamethasone for high-risk relapsed/refractory multiple myeloma

Abstract

High-risk multiple myeloma (MM) continues to have a poor prognosis and remains a therapeutic challenge. This phase 2 study evaluated the efficacy and safety of elotuzumab in combination with pomalidomide, carfilzomib, and low-dose dexamethasone for patients with high-risk relapsed/refractory (RR)MM (NCT03104270). Of 13 enrolled patients, 11 were evaluable for efficacy. Overall response rate and clinical benefit rate were 45.4% and 54.5%, respectively. Deep responses were observed including two complete responses. The novel quadruplet combination was overall well-tolerated, with clinically manageable adverse events. Common adverse events of ≥ grade 3 included lymphopenia (15%), anemia (15%), sepsis (15%), pneumonia (15%), and hypophosphatemia (15%). The novel combination showed promising efficacy and was well tolerated in this heavily pretreated MM population. Even though the study was terminated early prior to completion of enrollment, the results indicate that this may be a promising therapeutic approach for high-risk RRMM patients, which warrants further study.

Keywords:

• Multiple myeloma
• elotuzumab
• pomalidomide
• carfilzomib
• phase II

Acknowledgments

The authors would like to thank the patients for their contributions to the study and all healthcare professional staff involved in collecting clinical specimens. The medical writing support was provided by Talya Underwood, MPhil, of Anthos Communications Ltd, UK, funded by Oncotherapeutics, according to Good Publication Practice guidelines.

Disclosure statement

J.R. Berenson reports receiving consultant and speakers’ bureau honoraria from Bristol-Myers Squibb and AMGEN. This investigator-sponsored study was funded by Bristol-Myers Squibb and performed by Oncotherapeutics as the Clinical Research Organization.

Author contributions

JRB is a principal investigator designed this study. TMS and DY analyzed data. DM monitored, extracted, and provided data for the data analysis. MG, RAS, and BE collected data. GS, SE, SL, and RV reviewed and monitored this study. DY, TMS, and JRB wrote this manuscript.

Data accessibility

Access to study data will be granted upon request.

Additional information

Funding

Funding was provided by Bristol Myers Squibb