NCT07096778

Inobrodib, Pomalidomide and Dexamethasone in 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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: CellCentric Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 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).

Conditions

• Multiple Myeloma Refractory
• Multiple Myeloma in Relapse

Interventions

Type	Name	Description
DRUG	Inobrodib	20 mg orally twice daily (b.i.d.) 4 days on / 3 days off for each 28-day cycle.
DRUG	Pomalidomide	4 mg orally once daily on Day 1 to 21 of each 28-day cycle
DRUG	Dexamethasone	40 mg orally once daily on Days 1, 8, 15 and 22 for each 28-day cycle

Timeline

• Start date: 2026-01-22
• Primary completion: 2029-12-01
• Completion: 2029-12-01
• First posted: 2025-07-31
• Last updated: 2026-04-15

Locations

11 sites across 2 countries: United States, United Kingdom

Regulatory

• FDA-regulated drug study