Inobrodib + Pomalidomide + Dexamethasone for Multiple Myeloma

(DoMMino-1 Trial)

This trial examines a new treatment combination for multiple myeloma, a type of blood cancer that has returned after previous treatments failed. Researchers aim to assess how well inobrodib (an experimental treatment) works with pomalidomide and dexamethasone in combating the cancer and to understand any side effects. This trial suits individuals diagnosed with multiple myeloma that does not respond to current treatments. Participants will know which treatment they receive, as the study does not compare it with other treatments. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of people.

The trial requires that you stop taking any investigational agents, chemotherapy, immunotherapy, or anticancer agents from a previous study within 14 days or 5 half-lives before starting the study treatment. You also need to avoid medicines or supplements that interfere with the study treatment.

Previous studies have shown that the combination of inobrodib, pomalidomide, and dexamethasone has a manageable safety profile, with most side effects being mild and treatable by doctors. For instance, one study found that the safety results for inobrodib with pomalidomide and dexamethasone were similar to those expected from using pomalidomide and dexamethasone alone. Inobrodib has been tested in over 450 patients and has generally been well tolerated, with most patients not experiencing serious side effects. This combination has shown promise in treating patients who have already tried many other treatments.¹²³⁴⁵

Researchers are excited about the combination of Inobrodib, Pomalidomide, and Dexamethasone for treating multiple myeloma because it introduces a novel mechanism of action. Unlike standard treatments that mainly focus on targeting and destroying cancer cells, Inobrodib acts by inhibiting specific proteins called bromodomain and extra-terminal domain (BET) proteins, which play a crucial role in regulating cancer cell growth and survival. This unique approach has the potential to overcome resistance to existing therapies and offer new hope for patients who do not respond to current options like lenalidomide or bortezomib. Additionally, combining Inobrodib with Pomalidomide and Dexamethasone may enhance the overall effectiveness, providing a more powerful treatment option for this challenging condition.

Research has shown that combining inobrodib with pomalidomide and dexamethasone, the treatment under study in this trial, could effectively treat multiple myeloma, especially in patients unresponsive to other treatments. Studies found that over 70% of patients experienced at least some improvement, based on the International Myeloma Working Group criteria. Lab studies have demonstrated strong anti-cancer effects, and clinical trials have reported high success rates. Specifically, different doses resulted in 60% and 75% response rates in patients who had undergone many previous treatments. These encouraging results suggest that this treatment might offer significant benefits for patients with challenging cases of multiple myeloma.²³⁶⁷⁸