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6. Minimal Residual Disease in Myeloma: Application for Clinical Care and New Drug Registration

Author

Kenneth C. Anderson, Daniel Auclair, Stacey J. Adam, Amit Agarwal, Melissa Anderson, Hervé Avet-Loiseau, Mark Bustoros, Jessica Chapman, Dana E. Connors, Ajeeta Dash, Alessandra Di Bacco, Ling Du, Thierry Facon, Juan Flores-Montero, Francesca Gay, Irene M. Ghobrial, Nicole J. Gormley, Ira Gupta, Howard Higley, Jens Hillengass, Bindu Kanapuru, Dickran Kazandjian, Gary J. Kelloff, Ilan R. Kirsch, Brandon Kremer, Ola Landgren, Elizabeth Lightbody, Oliver C. Lomas, Sagar Lonial, María-Victoria Mateos, Rocio Montes de Oca, Lata Mukundan, Nikhil C. Munshi, Elizabeth K. O'Donnell, Alberto Orfao, Bruno Paiva, Reshma Patel, Trevor J. Pugh, Karthik Ramasamy, Jill Ray, Mikhail Roshal, Jeremy A. Ross, Caroline C. Sigman, Katie L. Thoren, Suzanne Trudel, Gary Ulaner, Nancy Valente, Brendan M. Weiss, Elena Zamagni, Shaji K. Kumar, Anderson K.C., Auclair D., Adam S.J., Agarwal A., Anderson M., Avet-Loiseau H., Bustoros M., Chapman J., Connors D.E., Dash A., Bacco A.D., Du L., Facon T., Flores-Montero J., Gay F., Ghobrial I.M., Gormley N.J., Gupta I., Higley H., Hillengass J., Kanapuru B., Kazandjian D., Kelloff G.J., Kirsch I.R., Kremer B., Landgren O., Lightbody E., Lomas O.C., Lonial S., Mateos M.-V., de Oca R.M., Mukundan L., Munshi N.C., Odonnell E.K., Orfao A., Paiva B., Patel R., Pugh T.J., Ramasamy K., Ray J., Roshal M., Ross J.A., Sigman C.C., Thoren K.L., Trudel S., Ulaner G., Valente N., Weiss B.M., Zamagni E., and Kumar S.K.

Subjects
Drug, Cancer Research, medicine.medical_specialty, Neoplasm, Residual, media_common.quotation_subject, MEDLINE, High-Throughput Nucleotide Sequencing, Disease, medicine.disease, Minimal residual disease, body regions, Clinical trial, Oncology, Bone Marrow, hemic and lymphatic diseases, medicine, Humans, Biomarker (medicine), MRD, Bone marrow–based technologies, next-generation flow, next-generation sequencing, multiple myeloma, Liquid biopsy, Multiple Myeloma, Intensive care medicine, Multiple myeloma, Retrospective Studies, media_common
Abstract

The development of novel agents has transformed the treatment paradigm for multiple myeloma, with minimal residual disease (MRD) negativity now achievable across the entire disease spectrum. Bone marrow–based technologies to assess MRD, including approaches using next-generation flow and next-generation sequencing, have provided real-time clinical tools for the sensitive detection and monitoring of MRD in patients with multiple myeloma. Complementary liquid biopsy–based assays are now quickly progressing with some, such as mass spectrometry methods, being very close to clinical use, while others utilizing nucleic acid–based technologies are still developing and will prove important to further our understanding of the biology of MRD. On the regulatory front, multiple retrospective individual patient and clinical trial level meta-analyses have already shown and will continue to assess the potential of MRD as a surrogate for patient outcome. Given all this progress, it is not surprising that a number of clinicians are now considering using MRD to inform real-world clinical care of patients across the spectrum from smoldering myeloma to relapsed refractory multiple myeloma, with each disease setting presenting key challenges and questions that will need to be addressed through clinical trials. The pace of advances in targeted and immune therapies in multiple myeloma is unprecedented, and novel MRD-driven biomarker strategies are essential to accelerate innovative clinical trials leading to regulatory approval of novel treatments and continued improvement in patient outcomes.

Published
2021
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