Study of Purinostat Mesylate with Pomalidomide and Low-Dose Dexamethasone for Relapsed or Refractory Multiple Myeloma Phase IbIIa Trial to Find Safe Dose and Evaluate Treatment Effects

What this Trial Is About

Researchers are evaluating the safety, tolerability, and optimal dosing of Purinostat Mesylate combined with fixed-dose Pomalidomide Capsules and low-dose Dexamethasone in patients with relapsed or refractory multiple myeloma RRMM. This Phase IbIIa clinical study aims to determine the maximum tolerated dose MTD and recommended Phase IIa dose RP2D while assessing the pharmacokinetics and preliminary efficacy of this combination therapy. The study involves two treatment regimens with different dosing schedules. In Regimen A, Purinostat Mesylate is given by intravenous infusion on Days 1, 4, 8, and 11 of a 21-day cycle, combined with oral Pomalidomide once daily for 14 days followed by a 7-day break, and oral Dexamethasone on Days 1, 4, 8, and 11. Regimen B uses a 28-day cycle with Purinostat Mesylate infusions on Days 1, 4, 15, and 18, Pomalidomide daily for 21 days followed by 7 days off, and Dexamethasone on Days 1, 4, 15, and 18. The study evaluates three different doses of Purinostat Mesylate 4 mgm2, 6 mgm2, and 8.4 mgm2. Participants will be monitored for dose-limiting toxicities, remission rates, and survival outcomes during each treatment cycle. Assessments include laboratory tests, physical exams, and safety evaluations to measure the therapys effects. The study also collects pharmacokinetic data to understand how the drugs behave in the body. Participation lasts through multiple 21- or 28-day cycles, with ongoing monitoring for safety and treatment response throughout the study.

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