Inobrodib with pomalidomide and dexamethasone for relapsed or refractory multiple myeloma
A Phase II, Open-Label, Multicenter Study of Inobrodib in Combination With Pomalidomide and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma
This test tries to see if adding inobrodib to pomalidomide and dexamethasone helps people whose multiple myeloma has returned or stopped responding after standard treatments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | CellCentric Ltd. Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 11 sites (Atlanta, Georgia and 10 other locations) |
| Trial ID | NCT07096778 on ClinicalTrials.gov |
What this trial studies
This is a Phase 2, open-label, multicenter trial enrolling about 100 adults with relapsed or refractory multiple myeloma who are refractory to at least one proteasome inhibitor, one anti‑CD38 antibody and to pomalidomide and who have previously received a bispecific T‑cell engager. Participants receive inobrodib 20 mg orally twice daily on a 4 days on / 3 days off schedule each 28‑day cycle alongside standard-dose pomalidomide (4 mg days 1–21) and dexamethasone (40 mg weekly). Treatment continues until disease progression, unacceptable toxicity, or other withdrawal criteria. The primary endpoint is objective response rate by IMWG criteria as reviewed by an independent committee, with safety and tolerability also closely monitored.
Who should consider this trial
Good fit: Adults (≥18) with relapsed or refractory multiple myeloma who are refractory to at least one proteasome inhibitor, one anti‑CD38 monoclonal antibody and pomalidomide, have prior bispecific T‑cell engager exposure, ECOG 0–2, and adequate organ function are the intended candidates.
Not a fit: People who are earlier in their treatment course (not yet treated with pomalidomide or a bispecific T‑cell engager), those with prior p300/CBP bromodomain inhibitor exposure, or those with significant organ dysfunction or allergies to the study drugs are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If successful, this combination could offer an additional treatment option that produces responses in patients whose myeloma no longer responds to currently approved therapies.
How similar studies have performed: Combining immunomodulatory drugs like pomalidomide with dexamethasone is an established approach in RRMM, but use of p300/CBP inhibitors such as inobrodib is relatively novel with limited clinical data to date.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Atlanta, Georgia and 10 other locations
- Winship Cancer Institute — Atlanta, Georgia, United States (Recruiting)
- American Oncology Partners, PA — Bethesda, Maryland, United States (Recruiting)
- University of Nebraska Medical Center — Omaha, Nebraska, United States (Recruiting)
- University of Pennsylvania, Abramson Cancer Center — Philadelphia, Pennsylvania, United States (Recruiting)
- The Christie NHS Foundation Trust — Withington, Greater Manchester, United Kingdom (Recruiting)
- Royal Marsden NHS Foundation Trust — Sutton, London, United Kingdom (Recruiting)
- The Clatterbridge Cancer Centre NHS Foundation Trust — Bebington, Wirral, United Kingdom (Recruiting)
- Western General Hospital — Edinburgh, United Kingdom (Recruiting)
- Barts Health NHS Trust — London, United Kingdom (Recruiting)
- King's College Hospital NHS Foundation Trust — London, United Kingdom (Recruiting)
- Imperial College Healthcare NHS Trust, Hammersmith Hospital — London, United Kingdom (Recruiting)
Study contacts
- Study coordinator: CCS1477-04 Clinical Operations
- Email: DOMMINO-1@cellcentric.com
- Phone: +44 1799 531130
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.