NCT06484829

Purinostat Mesylate Combined With Pomalidomide Capsules and Low-dose Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma

An Open-Label, Parallel-Controlled, Multi-Center Phase Ib/IIa Clinical Study to Evaluate the Efficacy and Safety of Purinostat Mesylate for Injection Combined With Pomalidomide Capsules and Low-Dose Dexamethasone in Patients With Relapsed and Refractory Multiple Myeloma

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: Chengdu Zenitar Biomedical Technology Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Primary Purpose Phase Ib. To determine the Maximum Tolerated Dose (MTD) and establish the Recommended Phase IIa Dose (RP2D) of Purinostat Mesylate for Injection combined with fixed-dose Pomalidomide Capsules and Dexamethasone in patients with relapsed or refractory multiple myeloma. Phase IIa. To further evaluate the safety and tolerability of Purinostat Mesylate for Injection at the RP2D combined with fixed-dose Pomalidomide Capsules and Dexamethasone in patients with relapsed and refractory multiple myeloma (RRMM). Secondary Objectives Phase Ib 1. To evaluate the safety and tolerability of Purinostat Mesylate for Injection combined with fixed-dose Pomalidomide Capsules and Dexamethasone in the treatment of relapsed or refractory multiple myeloma. 2. To assess the pharmacokinetic (PK) parameters of the combination therapy in patients with relapsed or refractory multiple myeloma. 3. To observe the preliminary efficacy of the combination therapy in patients with relapsed or refractory multiple myeloma. Phase IIa 1. To evaluate the preliminary efficacy of the combination therapy in patients with relapsed and refractory multiple myeloma (RRMM). 2. To characterize the population pharmacokinetic (PPK) profile of the combination therapy in patients with relapsed or refractory multiple myeloma (RRMM).

Conditions

• Relapsed or Refractory Multiple Myeloma (RRMM)

Interventions

Type	Name	Description
DRUG	Purinostat Mesylate 4 mg/m2	4 mg/m2 Purinostat Mesylate + 4mg Pomalidomide + 20mg Dexamethasone.
DRUG	Purinostat Mesylate 6 mg/m2	6 mg/m2 Purinostat Mesylate + 4mg Pomalidomide + 20mg Dexamethasone.
DRUG	Purinostat Mesylate 8.4 mg/m2	8.4 mg/m2 Purinostat Mesylate + 4mg Pomalidomide + 20mg Dexamethasone.

Timeline

• Start date: 2024-03-25
• Primary completion: 2026-02-01
• Completion: 2026-04-01
• First posted: 2024-07-03
• Last updated: 2025-04-02

Locations

1 site across 1 country: China