Starton Therapeutics has treated the first patient in a Phase 2a study (NCT06087653) testing STAR-LLD, a new continuous under-the-skin (subcutaneous) form of lenalidomide, for people with relapsed or refractory multiple myeloma.
Lenalidomide, sold as Revlimid, is commonly taken by mouth and is a standard treatment for multiple myeloma. However, when taken orally, the drug reaches high peak levels in the blood. These peaks can cause side effects such as low white blood cells (neutropenia) and low platelets (thrombocytopenia). Because of these side effects, doctors often need to lower the dose or stop treatment, which may reduce its long-term benefit.
STAR-LLD is designed to solve this problem by delivering lenalidomide slowly and continuously through a small pump under the skin. This method aims to avoid high toxic peaks, keep a steady effective drug level, improve immune activity, and reduce side effects.
In an earlier Phase 1b study of six patients who had received a median of two prior treatments, all patients responded to therapy. One patient had a complete response and five had partial responses, giving an overall response rate of 100%. No serious drug-related blood toxicities above Grade 2 were reported. Median progression-free survival was more than 10 months.
The current Phase 2a trial focuses on patients who are not eligible for transplant and are receiving second-line or later treatment. The study is comparing three different subcutaneous dose levels (combined with dexamethasone and a proteasome inhibitor) against the standard 25 mg oral dose. The main goal is to evaluate safety and tolerability over 12 months. Up to 69 patients will be enrolled, with completion expected in the first half of 2027.
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