Inobrodib with Pomalidomide and Dexamethasone vs Standard Therapy for Relapsed or Refractory Myeloma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 3, multicenter, open-label, randomized trial comparing InoPd to investigator’s choice of standard therapy (DPd, EPd, or Kd) in adults with relapsed or refractory multiple myeloma who have had 1–4 prior treatments. Participants are randomized 1:1 and receive treatment in 28‑day cycles until progression or unacceptable toxicity. The primary goals are to compare progression-free survival and objective response rate between arms, with secondary measures including overall survival, time to response, duration of response, minimal residual disease, quality of life, safety, and pharmacokinetics. A Steering Committee and an Independent Data Monitoring Committee oversee conduct and safety. Enrollment targets about 450 participants across sites, with lead sponsor CellCentric Ltd.

Why it matters

Who can join: the full rules

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

Where it's running

• Regis Clinical Research
  Miami, Florida, United States Recruiting

Study contacts

• Study coordinator: CCS1477-05 Clinical Operations
• Email: DOMMINO-2@cellcentric.com
• Phone: +44 1799 531130

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.