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Inobrodib, Pomalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma
Trial Status: active
The purpose of this study is to learn more about the anti-cancer activity of inobrodib,
when given in combination with pomalidomide and dexamethasone, in patients with multiple
myeloma that has come back following treatment and which no longer responds to available
therapies. The study treatment will not be compared to any other treatment and patients
will know what treatment they are receiving. This study will also further explore the
side effects of inobrodib in combination with these other medicines.
Inclusion Criteria
Male or female ≥18 years of age
Prior diagnosis of MM as defined according to IMWG criteria and relapsed or refractory to the last line of therapy
Eastern Co-operative Oncology Group (ECOG) performance status of 0 to 2
Adequate hematological, renal and hepatic function
Willingness to use highly effective contraceptive measures (if sexually active) with all sexual partners
Exclusion Criteria
Use of any investigational agent, chemotherapy, immunotherapy or anticancer agent from a previous clinical study within 14 days or 5 half-lives of first dose of study treatment, whichever is shortest; any antibody based therapy within 30 days
Prior treatment with p300/CBP bromodomain inhibitors
Known or suspected severe allergies to any active or inactive ingredients in the study medications (inobrodib, pomalidomide, dexamethasone) or any prior immunomodulatory drug (lenalidomide, thalidomide)
Treatment with medicines or herbal supplements or foods (e.g. strong CYP3A4 inducers or inhibitors) that would interfere with treatment
Major surgery within 4 weeks of the first dose of study treatment
Live vaccine within 4 weeks of study treatment
Active or unresolved adverse events
Active malignancies (progressing or requiring change in treatment) in the last 24 months other than multiple myeloma
Female patients who are pregnant or breast-feeding at any time during the study
Any illness or medical history that would impact safety or compliance with study requirements or impact ability to interpret study data
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07096778.