Medical Devices

FDA-NCI Roundtable: Symposium on Flow Cytometry Detection of Minimal Residual Disease in Multiple Myeloma, March 24, 2014

On March 24, 2014, an FDA-NCI roundtable symposium on minimal residual disease (MRD) detection in multiple myeloma (MM) was held at the FDA in Silver Spring, Maryland. The goal of this meeting was twofold: (1) to examine the evidence on the clinical utility of MRD in MM as a bio surrogate marker for drug response; and to (2) ascertain the status of consensus concerning the standardization of a flow cytometric device (assay), as well as its relationship to molecular tests, for the detection of MRD in MM. Over the past few years, three previous FDA workshops have been held to address MRD detection in acute lymphocytic leukemia (ALL), chronic lymphocytic leukemia (CLL), and acute myeloid leukemia (AML). Whilst the role of MRD is well established in these three hematological malignancies, its role in regulatory decisions within the agency remains in the realm of ongoing policy development.

And earlier NCI FDA meeting held at the NIH in Aug 2013 was based on the discussion surrounding the Blood editorial by Flanders, Stetler-Stevenson and Landgren from the NCI (Blood 8 August 2013 Vol 122 (6) pp 1088-89). This editorial discussed the heterogeneity of clinical laboratory practice in the flow cytometric analysis of MRD in MM. Given the current clinical importance of MRD in MM, a collaborative effort was called for the standardization of the flow cytometric detection of MRD in MM. A subsequent Leukemia editorial by SK Kumar and SV Rajkumar from the Mayo Clinic (Leukemia (2014) 28, 239–240) reported on the practical use of flow cytometry for the detection of MRD in MM. And we were aware that the International Clinical Cytometry Society (ICCS) formed a working group to establish consensus standardization for the flow cytometric detection of MRD (FC-MRD) in MM.

It was with this background that the current meeting began to discuss the clinical evidence for MRD as a surrogate biomarker for MM, the role of flow cytometry to date in the detection of MRD, and the future role of molecular and image detection of MRD in MM. The morning session began with an FDA overview and focused on the clinical aspects of MM. The morning session ended with a detailed panel discussion of several issues concerning the clinical use of MRD in MM. The afternoon session began with an overview of flow cytometry comparing it to pcr based molecular MRD. The afternoon presentations were centered around the emerging consensus regarding flow cytometry. The panel session considered issues regarding the reporting of clinical results. The meeting materials are listed below.

Page Last Updated: 07/11/2014
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