A Phase II, Open-Label, Multicenter Study of Inobrodib in Combination With Pomalidomide and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma
CellCentric Ltd.
Summary
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.
Description
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 tre…
Interventions
- DrugInobrodib
20 mg orally twice daily (b.i.d.) 4 days on / 3 days off for each 28-day cycle.
- DrugPomalidomide
4 mg orally once daily on Day 1 to 21 of each 28-day cycle
- DrugDexamethasone
40 mg orally once daily on Days 1, 8, 15 and 22 for each 28-day cycle
Locations (11)
- Winship Cancer InstituteAtlanta, Georgia
- American Oncology Partners, PABethesda, Maryland
- University of Nebraska Medical CenterOmaha, Nebraska
- University of Pennsylvania, Abramson Cancer CenterPhiladelphia, Pennsylvania
- The Christie NHS Foundation TrustWithington, Greater Manchester
- Royal Marsden NHS Foundation TrustSutton, London