Among some patients with transplant-eligible, newly diagnosed multiple myeloma (MM), a daratumumab, carfilzomib, lenalidomide, and dexamethasone (Dara-KRD) induction regimen is both safe and yields deep responses prior to autologous stem cell transplantation, according to research presented at the European Hematology Association (EHA) 2022 Hybrid Congress.
Patients with newly diagnosed MM with high-risk cytogenetic characteristics tend to have poorer outcomes, even if they are eligible for transplant. KRD has previously shown efficacy without excessive toxicity in this patient population, and adding Dara to this combination has shown potential as a therapeutic strategy.
The Intergroupe Francophone du Myelome is investigating the safety and efficacy of Dara-KRD as an induction and consolidation regimen when combined with double transplant among patients with newly diagnosed MM with high-risk cytogenetics. At the EHA 2022 Hybrid Congress, researchers presented analyses from the phase 2 2018-04 trial (ClinicalTrials.gov Identifier: NCT03606577) from this research group.
All patients had high-risk disease, which was determined by the presence of 17p deletion, 4;14 translocation, and/or 14;16 translocation. The primary endpoint was feasibility of Dara-KRD with double transplant.
Overall, 50 patients were included. The median patient age was 57 years (range, 38-65), and 24% of patients had stage III disease. All patients had high-risk cytogenetics based on the predefined criteria.
Of the 50 enrolled patients, 46 completed Dara-KRD induction. The overall response rate was 96%, and 92% of patients had at least a very good partial response. The rate of minimal residual disease negativity was 62% after induction.
Grade 3 or 4 adverse events related to treatment included neutropenia (38%), anemia (14%), thrombocytopenia (8%), infection (6%), renal insufficiency (6%), and deep-vein thrombosis (6%); 6% of patients had stem cell collection failure.
The authors noted that the study is ongoing, and longer follow-up data will be reported in the future.
Touzeau C, Perrrot A, Hulin C, et al. Daratumumab carfilzomib lenalidomide and dexamethasone as induction therapy in high-risk transplant eligible newly diagnosed myeloma patients: results of the phase 2 study IFM 2018-04. Presented at EHA 2022; June 9-12, 2022. Abstract S176.