IMS 2023 | GMMG-CONCEPT trial: Isa-KRd in high-risk newly diagnosed multiple myeloma

The GMMG-CONCEPT trial is Phase II trial, an academic investigator-initiated trial, conducted in 17 centers in Germany. It was directed solely at newly diagnosed high-risk myeloma patients, both transplant-eligible and transplant-non-eligible. The trial itself had two treatment arms, and these were according to transplant eligibility. All patients underwent treatment with Isa-KRd, (isatuximab, carfilzomib, lenalidomide, dexamethasone) for extended induction of six cycles and extended consolidation of four cycles, and then afterwards Isa-KR maintenance for two years. Transplant-eligible patients underwent high dose melphalan and transplant non-eligible patients received two additional cycles of Isa-KRd. The primary objective of the trial was to look at the MRD negativity rates at the end of consolidation (12-15 months after trial inclusion). Secondary, we also looked at sustained MRD-negativity and PFS. We were able to find that the trial met its primary endpoint, with MRD-negativity rates of 67.7%, so just over two-thirds, of transplant-eligible patients and 54.2% of transplant non-eligible patients. Importantly, these remissions were durable, because the rates of sustained MRD-negativity for at least one year were over 62.6% for the transplant-eligible, and almost 50% for transplant non-eligible patients. This is a promising sign that Isa-KRd can induce deep and long-lasting MRD-negative remissions in these solely high-risk myeloma patients. This also translated into a median progression-free survival that was not yet reached after median follow-up of 44 months, so we are getting close to… years, for transplant-eligible patients. For transplant-non-eligible patients, the follow-up was slightly shorter – close to three years, around 33 months.