The study design of the phase 3 LIGHTHOUSE study

The phase 3 LIGHTHOUSE study is a randomized, open-label, phase 3 study of melflufen and dexamethasone in combination with daratumumab compared to daratumumab with supporting dexamethasone in patients with relapsed and refractory multiple myeloma (RRMM) who are refractory to an immunomodulatory agent (IMiD) and a proteasome inhibitor (PI) or who have had at least three prior lines of therapy, including an IMiD and a PI.

The aim was to investigate the efficacy and safety of a combination therapy with melflufen plus daratumumab compared to daratumumab.

The clinical study was planned to include 240 patients and started in December 2020. 54 patients were included in the study before it was prematurely terminated in February 2022. 27 patients were randomized to each treatment arm. Patient characteristics were balanced between the two study arms. Top-line data was presented in November 2022.