💬In plain words
What the trial is, and whether it could suit you
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
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
* Adults aged 18 years or older (or the minimum age of consent under local rules, if that is 18 or over)
* A diagnosis of multiple myeloma that has either come back (relapsed) or did not respond (refractory) after the most recent treatment
* Myeloma that can be measured using standard study tests (blood and/or urine tests)
* Between 1 and 4 previous courses (lines) of myeloma treatment, which must have included both a treatment that targets CD38 (such as daratumumab or isatuximab) and lenalidomide
* Well enough to carry out daily activities with little or no help (Eastern Cooperative Oncology Group \[ECOG\] performance status of 0 to 2)
* Suitable blood test results and adequate kidney and liver function
* Willingness to use highly effective contraceptive measures (if sexually active) with all sexual partners
Exclusion Criteria:
* Recent anticancer treatment before starting study treatment: any experimental medicine, chemotherapy, immunotherapy or other anticancer treatment within 14 days or 5 half-lives (whichever is shorter), or certain antibody-based treatments within longer set periods
* Previous treatment with a medicine that works in the same way as inobrodib (a p300/CBP bromodomain inhibitor)
* Myeloma that has already stopped responding to pomalidomide (pomalidomide-refractory), unless only short-term pomalidomide was used and the study doctor confirms the person still meets the study rules
* Unable to receive at least one of the standard treatment options offered in the study, or unable/unwilling to follow the requirements for at least one of those options
* Taking medicines, herbal supplements or foods (for example, strong CYP3A4 inducers or inhibitors) that would interfere with the study treatment
* Major surgery within 4 weeks before the first dose of study treatment
* A live vaccine within 4 weeks before study treatment
* A recent stem cell transplant, or ongoing transplant-related problems such as graft-versus-host disease
* Myeloma affecting the brain, spinal fluid or spinal cord, or ongoing pressure on the spinal cord
* Another active cancer (progressing or needing a change in treatment) in the last 24 months, other than multiple myeloma, apart from certain low-risk or fully treated cancers
* Serious or uncontrolled medical problems, such as uncontrolled heart, lung, liver, bleeding or diabetes conditions, uncontrolled high blood pressure, or a heart-rhythm problem (including QT prolongation)
* An active or uncontrolled infection, including certain cases of HIV, hepatitis B or hepatitis C
* Digestive problems that could stop the study medicines being swallowed or properly absorbed
* Pregnant or breastfeeding, or planning to become pregnant, father a child or donate sperm during treatment or the required post-treatment period
* Any illness or medical history that could affect safety, the ability to follow study requirements, or the interpretation of study results
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