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 is to investigate the efficacy and safety of a combination therapy with melflufen plus daratumumab compared to daratumumab.
The study started in December 2020 and was planned to include 240 patients. In July 2021, the US Food and Drug Administration (FDA) requested a partial clinical hold of all studies with melflufen. Consequently, patient recruitment in LIGHTHOUSE was halted after 54 patients had been randomized.
The clinical study was prematurely terminated in February 2022. Twenty-seven patients were randomized to each treatment arm. Patient characteristics were balanced between the two study arms. Top-line data was presented in November 2022.