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

StatusRecruiting
PhasePhase 1/2
Started
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Record status
This record was last updated April 2, 2025 (before its estimated February 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Enrollment target: 126 to 144
    • Start date: Jun 26, 2024 to Mar 25, 2024
    • Interventions: Purinostat Mesylate 3mg/m2 (Drug), Purinostat Mesylate 4 mg/m2 (Drug), Purinostat Mesylate 6 mg/m2 (Drug), Purinostat Mesylate 8.4 mg/m2… to Purinostat Mesylate 4 mg/m2 (Drug), Purinostat Mesylate 6 mg/m2 (Drug), Purinostat Mesylate 8.4 mg/m2 (Drug)
    v3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    • Study title revised
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT06484829
Lead Sponsor Chengdu Zenitar Biomedical Technology Co., Ltd
Conditions
(from sponsor)		 Relapsed or Refractory Multiple Myeloma (RRMM)
Related terms Multiple Myeloma, Recurrence
Enrollment 144 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov