The GMMG-CONCEPT trial is an academic investigator initiated trial investigating quadruplet up front treatment as a combination of monoclonal anti-CD38 antibody, the isatuximab with carfilzomib, lenalidomide and dexamethasone. This trial included solely high risk patients defined by cytogenetic and all patients had also to have ISS stage 2 and 3 disease. The CONCEPT trial then investigated this quadruplet regimen, Isa-KRd, in induction, consolidation and also a triplet maintenance treatment. The trial includes transplant eligible and transplant non-eligible patients and transplant eligible patients undergo high dose melphalan treatment and stem cell transplantation after six cycles of Isa-KRd induction treatment.
Here at this year’s EHA and before at the ASCO we reported on the first fifty patients on response during the six induction treatment cycles. What we saw is that the overall response rate was 100% with 90% of patients achieving equal or more than a VGPR and 46% of patients achieving a CR or stringent CR. Three patients progressed during induction, 33 MRD evaluations were made and 20 of those 33 showed MRD negativity. Overall we saw a favourable toxicity profile, especially a low rate of peripheral neuropathy. So that the GMMG-CONCEPT trial shows, in our view, first promising results regarding MRD negativity in high risk multiple myeloma patients which hopefully translates into a better prognosis and underlines the importance of quadruplet frontline treatment in multiple myeloma.
The trial just completed recruitment in April 2020 with overall 153 patients. So far we don’t have the data on the primary endpoint which is MRD negativity after consolidation and we have no PFS data. We saw at ASCO and EHA the PFS data of the SWOG trial on high risk patients including a better comparable patient population with around 33-34 months which was unprecedented in this high risk patient population so far. So we hope that with a longer follow-up and now all patients included into the CONCEPT trial we can contribute to more data on high risk patients and their prognosis in the novel era of myeloma treatment.