Gene expression profiling impacts treatment decision making in newly diagnosed multiple myeloma patients in the prospective PROMMIS trial

• Type of Material: Article
• Authors: Noa Biran, Hackensack University Medical Center; Binod Dhakal, Medical College of Wisconsin; Suzanne Lentzsch, Columbia University; David Siegel, Hackensack University Medical Center; Saad Z Usmani, Levine Cancer Institute; Adriana Rossi, Weill Cornell Medicine; Care Rosenbaum, Weill Cornell Medicine; Divaya Bhutani, Columbia University; David H Vesole, Hackensack University Medical Center; Cesar Rodriguez, Wake Forest Baptist Comprehensive Cancer Center; Ajay Nooka, Emory University; Frits van Rhee, University of Arkansas of Medical Sciences; Lisette Stork-Sloots, Medex15; Femke de Snoo, Medex15; Pritish K Bhattacharyya, Hackensack University Medical Center; Durga Prasad Dash, Versiti Blood Center of Wisconsin; Sena Zümrütçü, SkylineDx; Martin H van Vliet, SkylineDx; Parameswaran Hari, Medical College of Wisconsin; Ruben Niesvizky, Weill Cornell Medical Center
• Language: English
• Date: 2021-08-01
• Publisher: John Wiley & Sons Ltd
• Publication Version: Final Published Version
• Copyright Statement: © 2021 The Authors. eJHaem published by British Society for Haematology and John Wiley & Sons Ltd.
• License: Creative Commons Attribution 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1002/jha2.209
• Title of Journal or Parent Work: EJHaem
• Volume: 2
• Issue: 3
• Start Page: 375
• End Page: 384
• Grant/Funding Information: The PROMMIS study (ClinicalTrials.gov Identifier: NCT02911571) was sponsored by SkylineDx.
• Keywords: gene expression; gene arrays; clinical trials; multiple myeloma
• Research Categories: Health Sciences, Oncology; Health Sciences, Medicine and Surgery

Abstract

Multiple myeloma (MM) is a heterogeneous hematologic malignancy associated with several risk factors including genetic aberrations which impact disease response and survival. Thorough risk classification is essential to select the best clinical strategy to optimize outcomes. The SKY92 molecular signature classifies patients as standard‐ or high‐risk for progression. The PRospective Observational Multiple Myeloma Impact Study (PROMMIS; NCT02911571) measures impact of SKY92 on risk classification and treatment plan. Newly diagnosed MM patients had bone marrow aspirates analyzed for SKY92. Physicians completed a questionnaire for each patient capturing risk classification, hypothetical treatment plan, and physician confidence in the treatment plan, before and after unblinding SKY92. One hundred forty seven MM patients were enrolled. Before unblinding SKY92, physicians regarded 74 (50%) patients as clinical standard‐risk. After unblinding SKY92, 16 patients were re‐assigned as high‐risk by the physician, and for 15 of them treatment strategy was impacted, resulting in an escalated treatment plan. For the 73 (50%) clinical high‐risk patients, SKY92 indicated 46 patients to be standard‐risk; for 31 of these patients the treatment strategy was impacted consistent with a de‐escalation of risk. Overall, SKY92 impacted treatment decisions in 37% of patients (p < 0.001). For clinical decision‐making, physicians incorporated SKY92, and the final assigned clinical risk was in line with SKY92 for 89% of patients. Furthermore, SKY92 significantly increased the confidence of the physicians’ treatment decisions (p < 0.001). This study shows potential added value of SKY92 in MM for treatment decision making.