RecruitingPhase 1Phase 2NCT06484829

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

Sponsor

Chengdu Zenitar Biomedical Technology Co., Ltd

Enrollment

144 participants

Start Date

Mar 25, 2024

Study Type

INTERVENTIONAL

Conditions

Relapsed or Refractory Multiple Myeloma (RRMM)

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).

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination of three drugs — purinostat mesylate, pomalidomide, and low-dose dexamethasone — in people with multiple myeloma (a bone marrow cancer) whose disease has returned or stopped responding to earlier treatments. **You may be eligible if...** - You are between 18 and 75 years old - You have multiple myeloma that has relapsed or is no longer responding to treatment - You have previously been treated with lenalidomide and a proteasome inhibitor (e.g., bortezomib) - You are willing to use contraception throughout the study **You may NOT be eligible if...** - This is your first time being treated for multiple myeloma - You have not previously received lenalidomide or a proteasome inhibitor - You have severe organ dysfunction - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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