Inobrodib, Pomalidomide and Dexamethasone Versus Standard Available Therapy in Relapsed or Refractory Multiple Myeloma
A Phase 3, Multicenter, Open-Label, Randomized Study to Evaluate Inobrodib in Combination With Pomalidomide and Dexamethasone Versus Standard Available Therapy in Patients With Relapsed or Refractory Multiple Myeloma
CellCentric Ltd.
450 participants
Aug 1, 2026
INTERVENTIONAL
Conditions
Summary
The main purpose of this study is to find out whether inobrodib, when given with pomalidomide and dexamethasone, works better than standard treatment for people whose multiple myeloma has come back or has not improved after previous treatment. The study will look at how long people taking part in the study ("Participants") live without their myeloma getting worse, and how many people's myeloma improves (responds) following treatment. The study will also look at how long participants live overall, how quickly treatment works, how long the response lasts, whether very small amounts of myeloma can still be found after a good response, quality of life, side effects, and the amount of inobrodib in the blood. Participants receive treatment in 28-day cycles. One group receives inobrodib by mouth twice a day for 4 days, followed by 3 days without inobrodib each week; pomalidomide by mouth once a day on Days 1 to 21 of each cycle; and dexamethasone once each week. The other group receives 1 standard treatment chosen by the study doctor from the following treatment options: daratumumab, pomalidomide, and dexamethasone; elotuzumab, pomalidomide, and dexamethasone; or carfilzomib and dexamethasone. Some standard treatments are given by injection or infusion at the study site. Other medicines, such as tablets or capsules, may be taken by mouth as instructed by the study team. Study checks include questions about symptoms and side effects, review of other medicines, physical checks, blood pressure and other vital sign checks, heart tracing tests, blood and urine tests, scans where needed, bone marrow samples, and questionnaires about symptoms and daily life. Participants in the inobrodib group will have extra blood samples to measure the amount of inobrodib in the blood. Some participants may also have extra research blood samples at selected visits.
Eligibility
Plain Language Summary
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This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Inobrodib in combination with pomalidomide and dexamethasone. Inobrodib 20 mg orally (PO) twice daily (b.i.d.), 4 days on/3 days off. Pomalidomide 4 mg PO once daily (o.d.) on Days 1 to 21 of each 28-day cycle. Dexamethasone 40 mg PO every week (q1w) (20 mg if \>75 years old) on Days 1, 8, 15 and 22 of each 28-day cycle. Treatment will continue until progressive disease, death, unacceptable side effects, withdrawal of consent or end of study, whichever occurs first.
Investigator's choice of elotuzumab in combination with pomalidomide and dexamethasone (EPd), daratumumab in combination with pomalidomide and dexamethasone (DPd), or carfilzomib in combination with dexamethasone (Kd). Treatment will continue until progressive disease, death, unacceptable side effects, withdrawal of consent or end of study, whichever occurs first.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07772024