Puesta Mesylate Combined With Pomalidomide Capsules and Low-dose Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma
NCT Number: NCT06484829
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Relapsed or Refractory Multiple Myeloma (RRMM)
Interventions: DRUG: Purinostat Mesylate 3mg/m2|DRUG: Purinostat Mesylate 4 mg/m2|DRUG: Purinostat Mesylate 6 mg/m2|DRUG: Purinostat Mesylate 8.4 mg/m2
Sponsor: Chengdu Zenitar Biomedical Technology Co., Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 126
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-06-26
Completion Date: 2026-04-01
Locations: West China Hospital Sichuan University, Chengdu, Sichuan, 610000, China

Summary:
Primary Purpose Phase Ib. Determine the maximum tolerated dose (MTD) of poystat mesylate for injection in combination with fixed-dose pomalidomide capsules and dexamethasone in patients with relapsed or refractory multiple myeloma (RRMM) at the recommended phase IIa dose (RP2D).

Phase IIa. To further evaluate the preliminary efficacy of the RP2D dose of puesta mesylate for injection in combination with fixed-dose pomalidomide capsules and dexamethasone in patients with relapsed or refractory multiple myeloma (RRMM).

Secondary Objectives Phase Ib

1. to evaluate the safety and tolerability of puesta mesylate for injection in combination with fixed-dose pomalidomide capsules and dexamethasone in the treatment of patients with relapsed or refractory multiple myeloma (RRMM);
2. to evaluate the pharmacokinetic and pharmacodynamic indices after combining fixed-dose pomalidomide capsule and dexamethasone with puesta mesylate for injection in patients with relapsed or refractory multiple myeloma (RRMM);
3. to observe the efficacy of injectable puesta mesylate combined with fixed-dose pomalidomide capsules and dexamethasone in patients with relapsed or refractory multiple myeloma (RRMM).

Phase IIa

1. To evaluate the safety and tolerability of puesta mesylate for injection in combination with fixed-dose pomalidomide capsules and dexamethasone in patients with relapsed or refractory multiple myeloma (RRMM).
2. To evaluate the population pharmacokinetic profile of puesta mesylate for injection in combination with fixed-dose pomalidomide capsules and dexamethasone in patients with relapsed or refractory multiple myeloma (RRMM).

Primary Outcome Measures: Dose-limiting toxicity (DLT), One or more unacceptable toxic reactions following administration of the drug, resulting in the inability to continue increasing the dose or prolonging the dosing cycle, Day 21/Day 28|Maximum Tolerated Dose (MTD), The maximum dose or concentration of a drug that does not cause death in experimental animals in experiments other than acute toxicity animal experiments (short-term repetitive experiments, subchronic toxicity experiments, chronic toxicity experiments)., Day 21/Day 28|Objective remission rate (ORR), Defined as the proportion of subjects achieving a strict complete remission (sCR) + complete remission (CR) + very good partial remission (VGPR) + partial remission (PR);, Day 21/Day 28
Secondary Outcome Measures: Complete Remission Rate (CRR), Proportion of subjects with sCR+CR, Day 21/Day 28|Duration of efficacy (DOR), Duration of first remission (PR and above) to disease progression or death;, Day 21/Day 28|Time to Relief (TTR), Time from first dose to PR and beyond, Day 21/Day 28|Progression-free survival (PFS), Time from first dose to disease progression or death, Day 21/Day 28|Overall survival (OS), Time from first dose to death from all causes, Day 21/Day 28