Phase II Study of Inobrodib With Pomalidomide and Dexamethasone for Adults With Relapsed or Resistant Multiple Myeloma

What this Trial Is About

Researchers are evaluating the anti-cancer effects of inobrodib combined with pomalidomide and dexamethasone in adults with multiple myeloma that has returned after treatment and no longer responds to available therapies. This Phase II, open-label, multicenter study focuses on patients refractory to certain prior treatments, including proteasome inhibitors, anti-CD38 monoclonal antibodies, pomalidomide, and bispecific T-cell engagers. The study also examines the side effects of this combination treatment. Participants will receive 20 mg of inobrodib orally twice daily for 4 days on and 3 days off in each 28-day cycle. Pomalidomide is administered orally at 4 mg once daily from Day 1 to 21, and dexamethasone at 40 mg orally on Days 1, 8, 15, and 22 of each cycle. Treatment continues until disease progression, unacceptable toxicity, new anticancer therapy initiation, or study withdrawal. Approximately 100 patients will be treated following this schedule. During the study, participants will be regularly evaluated for treatment response using International Myeloma Working Group criteria by an Independent Review Committee. Researchers will monitor objective response rate, duration and time to response, progression-free survival, overall survival, and side effects including adverse events and laboratory changes. Safety assessments will continue for 28 days after treatment ends, with follow-up lasting up to 48 months from enrollment.

Inobrodib, Pomalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma