HLX15-SC vs DARZALEX FASPRO for Multiple Myeloma

This trial tests a new treatment called HLX15-SC (an experimental drug) to compare it with an existing drug, DARZALEX FASPRO, for people with multiple myeloma who cannot undergo a stem cell transplant. Researchers aim to understand how the body processes the new drug, its safety, and its effectiveness. Participants will receive either the new treatment or DARZALEX FASPRO for four cycles, approximately 16 weeks. Individuals newly diagnosed with multiple myeloma who have not yet started treatment might be suitable for this trial. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

The trial information does not specify if you need to stop taking your current medications. However, it does mention that patients should not have had prior systemic therapy for multiple myeloma, except for a short course of corticosteroids. It's best to discuss your current medications with the trial team to get a clear answer.

Research shows that HLX15-SC is generally well-tolerated in clinical trials. Previous studies on HLX15-IV, a similar drug, found its safety profile and bodily reactions comparable to other multiple myeloma treatments. This suggests HLX15-SC might also be safe, though specific safety data for this version is still being collected.

In contrast, US-DARZALEX FASPRO® has a well-established safety record. Studies involving 1,446 patients with multiple myeloma reported injection site reactions, such as redness or swelling, in 8% of cases. The most common side effects were upper respiratory infections, affecting 20% or more of users. Although some serious reactions have been reported, they remain rare.

Researchers are excited about HLX15-SC for multiple myeloma because it introduces a new delivery method that could offer greater convenience for patients. Unlike standard treatments like DARZALEX FASPRO®, which are typically administered intravenously, HLX15-SC is delivered subcutaneously, potentially making treatment faster and more comfortable. This new approach could also improve patient adherence to the treatment regimen, which is crucial for managing multiple myeloma effectively. Additionally, the investigational treatment may offer a more targeted action, possibly enhancing its efficacy and safety profile compared to existing options.

This trial will compare HLX15-SC with DARZALEX FASPRO® for treating multiple myeloma. Studies have shown that DARZALEX FASPRO® effectively treats multiple myeloma, with many patients responding well. Research indicates it significantly slows disease progression. HLX15-SC, another treatment option in this trial, targets CD38, a protein on multiple myeloma cells, in the same way. Early research suggests that HLX15-SC behaves similarly in the body and triggers a similar immune response as DARZALEX FASPRO®. This suggests HLX15-SC might also effectively reduce multiple myeloma cells.¹²³⁵⁶