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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07096778.
Locations matching your search criteria
United States
California
San Francisco
University of California San FranciscoStatus: Approved
Contact: UCSF Clinical Trials
Phone: 877-827-3222
This is a Phase II, open-label, multicenter study to evaluate the efficacy and safety of
inobrodib in combination with pomalidomide and dexamethasone (InoPd) in patients with
relapsed and refractory multiple myeloma (RRMM).
Patients must be 18 years or older and be refractory to least one proteosome inhibitor
(PI), one anti-CD38 monoclonal antibody (mAb) and pomalidomide. Patients must also be
previously treated with an approved bispecific T-cell engager [TCE].
Approximately 100 patients will be treated with 20 mg of inobrodib administered orally
twice daily (b.i.d.) 4 days on / 3 days off for each 28-day cycle. Pomalidomide and
dexamethasone will be administered as per standard of care (SoC), i.e., with a starting
dose of 4 mg orally once daily on Day 1 to 21 of each 28-day cycle for pomalidomide, and
40 mg orally once daily on Days 1, 8, 15 and 22 for each 28-day cycle for dexamethasone.
Study treatment should be continued until disease progression, initiation of new
anticancer therapy, unacceptable toxicity or the patient meets any criteria for
withdrawal from the study.
The primary objective is to assess the efficacy of InoPd in terms of objective response
rate (ORR) based on International Myeloma Working Group (IMWG) criteria and assessed by
Independent Review Committee (IRC).
Lead OrganizationCellCentric Ltd.
Principal InvestigatorNaseer Qayum