FORTE trial: Minimal residual disease evaluation in newly diagnosed multiple myeloma

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Published: 11 Jun 2020
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Dr Stefania Oliva - GIMEMA, European Myeloma Network, Italy

Dr Stefania Oliva speaks to ecancer about the results of the FORTE trial, presented as part of the ASCO 2020 Virtual Meeting.

The phase III trial looked at multiparameter flow cytometry and next-generation sequencing for minimal residual disease evaluation in newly diagnosed multiple myeloma patients.

Prof Oliva explains how the techniques were used in the trial and reports that the results indicate that both techniques are good, but that longer follow-up is needed.

ecancer's filming has been kindly supported by Amgen through the ecancer Global Foundation. ecancer is editorially independent and there is no influence over content.

The FORTE trial is an important randomised phase III trial in which patients with multiple myeloma, with newly diagnosed multiple myeloma, who were eligible for transplantation, so patients younger than 65 years, were enrolled. In this poster I present the data about the role of minimal residual disease by evaluating both flow cytometry and NGS.

Briefly, patients in the FORTE trial were randomised to receive three kinds of therapy. The first arm enrolled patients who received four cycles of KCd, carfilzomib, cyclophosphamide and dexamethasone followed by transplantation and then consolidation with another four cycles of KCd. The second arm enrolled patients who received KRd, carfilzomib, lenalidomide, dexamethasone as induction followed by transplantation and followed by consolidation with another four cycles of KRd. Then the third arm enrolled patients who received KRd without transplantation, so induction followed by eight cycles of KRd consolidation. Finally, patients were randomised to receive lenalidomide alone or plus carfilzomib until progression.

Before maintenance we evaluated MRD by flow. Flow was evaluated in patients achieving a steady GPR but NGS only in patients with a CR. So in this analysis we focussed in patients on CR and we observed a good correlation between the two techniques. In particular, the rates of MRD negativity were concordant in the three arms. So in the intention to treat analysis we observed a higher rate of MRD negativity by flow in the KRd transplantation and the KRd twelve than in KCd. And in patients achieving CR we observed a higher rate of MRD negativity by NGS and flow in KRd transplantation versus the other two arms.

Then we evaluated the role of sustained MRD negativity. We observed a high rate of sustained MRD negativity both by NGS and flow. Finally, the correlation between the two techniques we observed a general agreement of 86% when the sensitivity was 10-5 and almost 80% at a sensitivity of 10-6.

Of course our conclusions are that the two techniques are good and a longer follow-up, of course, is needed to confirm the role of MRD in survival, so progression free survival and overall survival.

The follow-up now is not still mature to evaluate the PFS. We will present some data at the ASH meeting. So we will evaluate also the role of MRD in this sense.

Now in this period of the multiple myeloma setting we need to insert MRD in all clinical trials as a surrogate for progression free survival and overall survival. MRD and both techniques of flow and NGS are good, there are some disagreements but the higher is the sensitivity the better is the outcome. So our conclusions are that both techniques are good and are essential to evaluate the rate of MRD negativity between different treatment arms and different treatment strategies for myeloma.