International harmonization in performing and reporting minimal residual disease assessment in multiple myeloma trials

Author:

Costa Luciano J.ORCID,Derman Benjamin A.ORCID,Bal Susan,Sidana SurbhiORCID,Chhabra Saurabh,Silbermann Rebecca,Ye Jing C.,Cook GordonORCID,Cornell Robert F.,Holstein Sarah A.ORCID,Shi Qian,Omel James,Callander Natalie S.,Chng Wee Joo,Hungria Vania,Maiolino AngeloORCID,Stadtmauer Edward,Giralt SergioORCID,Pasquini Marcelo,Jakubowiak Andrzej J.,Morgan Gareth J.,Krishnan Amrita,Jackson Graham H.,Mohty Mohamad,Mateos Maria VictoriaORCID,Dimopoulos Meletious A.,Facon Thierry,Spencer Andrew,Miguel Jesus San,Hari Parameswaran,Usmani Saad Z.,Manier Salomon,McCarthy Phillip,Kumar ShajiORCID,Gay Francesca,Paiva BrunoORCID

Publisher

Springer Science and Business Media LLC

Subject

Oncology,Cancer Research,Hematology

Reference78 articles.

1. Holstein SA, Howard A, Avigan D, Bhutani M, Cohen AD, Costa LJ, et al. Summary of the 2019 Blood and Marrow Transplant Clinical Trials Network Myeloma Intergroup Workshop on Minimal Residual Disease and Immune Profiling. Biol Blood Marrow Transplant. 2020;26:e7–e15.

2. Kumar S, Paiva B, Anderson KC, Durie B, Landgren O, Moreau P, et al. International Myeloma Working Group consensus criteria for response and minimal residual disease assessment in multiple myeloma. Lancet Oncol. 2016;17:e328–46.

3. US FDA. Hematologic malignancies: regulatory considerations for use of minimal residual disease in development of drug and biological products for treatment-guidance for industry. 2020. https://www.fda.gov/media/134605/download. Accessed May 2020.

4. EMA. Guideline on the use of minimal residual disease as a clinical endpoint in multiple myeloma studies. 2018. https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-use-minimal-residual-disease-clinical-endpoint-multiple-myeloma-studies_en.pdf.

5. Shi Q, Flowers CR, Hiddemann W, Marcus R, Herold M, Hagenbeek A, et al. Thirty-month complete response as a surrogate end point in first-line follicular lymphoma therapy: an individual patient-level analysis of multiple randomized trials. J Clin Oncol. 2017;35:552–60.

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