FDA IDE validation of multiple myeloma MRD test by flow cytometry

被引：2

作者：

Jevremovic, Dragan ^{[1
]}

Shi, Min ^{[1
]}

Horna, Pedro ^{[1
]}

Otteson, Gregory E. ^{[1
]}

Timm, Michael M. ^{[1
]}

Bennett, Shannon A. ^{[2
]}

Baughn, Linda B. ^{[1
,3
]}

Greipp, Patricia T. ^{[1
,3
]}

Gonsalves, Wilson I. ^{[4
]}

Kapoor, Prashant ^{[4
]}

Gertz, Morie A. ^{[4
]}

Binder, Moritz ^{[4
]}

Buadi, Francis K. ^{[4
]}

Dispenzieri, Angela ^{[4
]}

Kourelis, Taxiarchis ^{[4
]}

Muchtar, Eli ^{[4
]}

Zhou, Jiehao ^{[5
]}

Rajkumar, S. Vincent ^{[4
]}

Kumar, Shaji K. ^{[4
]}

Olteanu, Horatiu ^{[1
]}

机构：

[1] Mayo Clin, Div Hematopathol, Rochester, MN USA

[2] Mayo Clin, Qual Unit, Rochester, MN USA

[3] Mayo Clin, Dept Lab Med & Pathol, Div Lab Genet & Genom, Rochester, MN USA

[4] Mayo Clin, Dept Med, Div Hematol, Rochester, MN USA

[5] Mayo Clin, Dept Lab Med & Pathol, Scottsdale, AZ USA

来源：

AMERICAN JOURNAL OF HEMATOLOGY | 2024年 / 99卷 / 12期

关键词：

MINIMAL RESIDUAL DISEASE;

D O I：

10.1002/ajh.27484

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

引用

页码：2399 / 2401

页数：3

共 14 条

[1] Minimal Residual Disease in Myeloma: Application for Clinical Care and New Drug Registration
Anderson, Kenneth C.
Auclair, Daniel
Adam, Stacey J.
Agarwal, Amit
Anderson, Melissa
Avet-Loiseau, Herve
Bustoros, Mark
Chapman, Jessica
Connors, Dana E.
Dash, Ajeeta
Di Bacco, Alessandra
Du, Ling
Facon, Thierry
Flores-Montero, Juan
Gay, Francesca
Ghobrial, Irene M.
Gormley, Nicole J.
Gupta, Ira
Higley, Howard
Hillengass, Jens
Kanapuru, Bindu
Kazandjian, Dickran
Kelloff, Gary J.
Kirsch, Ilan R.
Kremer, Brandon
Landgren, Ola
Lightbody, Elizabeth
Lomas, Oliver C.
Lonial, Sagar
Mateos, Maria-Victoria
de Oca, Rocio Montes
Mukundan, Lata
Munshi, Nikhil C.
O'Donnell, Elizabeth K.
Orfao, Alberto
Paiva, Bruno
Patel, Reshma
Pugh, Trevor J.
Ramasamy, Karthik
Ray, Jill
Roshal, Mikhail
Ross, Jeremy A.
Sigman, Caroline C.
Thoren, Katie L.
Trudel, Suzanne
Ulaner, Gary
Valente, Nancy
Weiss, Brendan M.
Zamagni, Elena
Kumar, Shaji K.
[J]. CLINICAL CANCER RESEARCH, 2021, 27 (19) : 5195 - 5212
[2] [Anonymous], 2018, Cancer Discov, V8, pOF6, DOI 10.1158/2159-8290.CD-NB2018-136
[3] Minimal Residual Disease Status as a Surrogate Endpoint for Progression-free Survival in Newly Diagnosed Multiple Myeloma Studies: A Meta-analysis
Avet-Loiseau, Herve
Ludwig, Heinz
Landgren, Ola
Paiva, Bruno
Morris, Chris
Yang, Hui
Zhou, Kefei
Ro, Sunhee
Mateos, Maria-Victoria
[J]. CLINICAL LYMPHOMA MYELOMA & LEUKEMIA, 2020, 20 (01) : E30 - E37
[4] Analytical evaluation of the clonoSEQ Assay for establishing measurable (minimal) residual disease in acute lymphoblastic leukemia, chronic lymphocytic leukemia, and multiple myeloma
Ching, Travers
Duncan, Megan E.
Newman-Eerkes, Tera
McWhorter, Mollie M. E.
Tracy, Jeffrey M.
Steen, Michelle S.
Brown, Ryan P.
Venkatasubbarao, Srivatsa
Akers, Nicholas K.
Vignali, Marissa
Moorhead, Martin E.
Watson, Drew
Emerson, Ryan O.
Mann, Tobias P.
Cimler, B. Melina
Swatkowski, Pamela L.
Kirsch, Ilan R.
Sang, Charles
Robins, Harlan S.
Howie, Bryan
Sherwood, Anna
[J]. BMC CANCER, 2020, 20 (01)
[5] FDA, 2024, MEDICAL DEVICES LAB, P37286
[6] Next Generation Flow for highly sensitive and standardized detection of minimal residual disease in multiple myeloma
Flores-Montero, J.
Sanoja-Flores, L.
Paiva, B.
Puig, N.
Garcia-Sanchez, O.
Boettcher, S.
van der Velden, V. H. J.
Perez-Moran, J-J
Vidriales, M-B
Garcia-Sanz, R.
Jimenez, C.
Gonzalez, M.
Martinez-Lopez, J.
Corral-Mateos, A.
Grigore, G-E
Fluxa, R.
Pontes, R.
Caetano, J.
Sedek, L.
del Canizo, M-C
Blade, J.
Lahuerta, J-J
Aguilar, C.
Barez, A.
Garcia-Mateo, A.
Labrador, J.
Leoz, P.
Aguilera-Sanz, C.
San-Miguel, J.
Mateos, M-V
Durie, B.
van Dongen, J. J. M.
Orfao, A.
[J]. LEUKEMIA, 2017, 31 (10) : 2094 - 2103
[7] International Myeloma Foundation, A historic turning point: ODAC unanimously votes in favor of MRD testing as an early endpoint in myeloma clinical trials to support accelerated approvals of new treatments
[8] International Myeloma Working Group consensus criteria for response and minimal residual disease assessment in multiple myeloma
Kumar, Shaji
Paiva, Bruno
Anderson, Kenneth C.
Durie, Brian
Landgren, Ola
Moreau, Philippe
Munshi, Nikhil
Lonial, Sagar
Blade, Joan
Mateos, Maria-Victoria
Dimopoulos, Meletios
Kastritis, Efstathios
Boccadoro, Mario
Orlowski, Robert
Goldschmidt, Hartmut
Spencer, Andrew
Hou, Jian
Chng, Wee Joo
Usmani, Saad Z.
Zamagni, Elena
Shimizu, Kazuyuki
Jagannath, Sundar
Johnsen, Hans E.
Terpos, Evangelos
Reiman, Anthony
Kyle, Robert A.
Sonneveld, Pieter
Richardson, Paul G.
McCarthy, Philip
Ludwig, Heinz
Chen, Wenming
Cavo, Michele
Harousseau, Jean-Luc
Lentzsch, Suzanne
Hillengass, Jens
Palumbo, Antonio
Orfao, Alberto
Rajkumar, S. Vincent
Miguel, Jesus San
Avet-Loiseau, Herve
[J]. LANCET ONCOLOGY, 2016, 17 (08) : E328 - E346
[9] EVIDENCE meta-analysis: evaluating minimal residual disease as an intermediate clinical end point for multiple myeloma
Landgren, Ola
Prior, Thomas J.
Masterson, Tara
Heuck, Christoph
Bueno, Orlando F.
Dash, Ajeeta B.
Einsele, Hermann
Goldschmidt, Hartmut
Knop, Stefan
Li, Cong
Mellqvist, Ulf-Henrik
McFadden, Ian
Oprea, Corina
Ross, Jeremy A.
Talpes, Mihaela
Hydren, Jay R.
Ahlstrom, Jennifer M.
Kazandjian, Dickran
Weinhold, Niels
Zhang, Rick
Stetler-Stevenson, Maryalice
Marti, Gerald
Devlin, Sean M.
[J]. BLOOD, 2024, 144 (04) : 359 - 367
[10] Novel multi-parameter flow cytometry sensitively detects phenotypically distinct plasma cell subsets in plasma cell proliferative disorders
Morice, W. G.
Hanson, C. A.
Kumar, S.
Frederick, L. A.
Lesnick, C. E.
Greipp, P. R.
[J]. LEUKEMIA, 2007, 21 (09) : 2043 - U1

← 1 2 →