OncoMatch/Clinical Trials/NCT06484829
Purinostat Mesylate Combined With Pomalidomide Capsules and Low-dose Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma
Is NCT06484829 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Purinostat Mesylate 4 mg/m2 and Purinostat Mesylate 6 mg/m2 for relapsed or refractory multiple myeloma (rrmm).
Treatment: Purinostat Mesylate 4 mg/m2 · Purinostat Mesylate 6 mg/m2 · Purinostat Mesylate 8.4 mg/m2 — 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).
Check if I qualifyExtracted eligibility criteria
Cancer type
Multiple Myeloma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: lenalidomide (lenalidomide)
must include lenalidomide
Must have received: proteasome inhibitor
must include ... proteasome inhibitors
Cannot have received: histone deacetylase (HDAC) inhibitor
Exception: cedarbenazine
prior antitumor therapy with histone deacetylase (HDAC) inhibitors (except cedarbenazine)
Cannot have received: antibody-coupled degradation agent (DAC)
prior antitumor therapy with ... antibody-coupled degradation agents (DAC)
Cannot have received: HSP90 inhibitor
prior antitumor therapy with ... HSP90 inhibitors
Cannot have received: valproic acid (valproic acid)
prior antitumor therapy with ... valproic acid
Cannot have received: pomalidomide (pomalidomide)
Exception: disease progression following prior treatment with standard dose pomalidomide
disease progression following prior treatment with standard dose pomalidomide
Lab requirements
Blood counts
ANC ≥ 1.0 x 10^9/L (without G-CSF within 7 days, except if ≥50% plasma cells in marrow); PLT ≥75 × 10^9/L (no platelet transfusion or TPO within 7 days, or ≥50 × 10^9/L if ≥50% plasma cells in marrow); Hemoglobin ≥ 80 g/L (no RBC transfusion or EPO within 7 days)
Kidney function
GFR ≥ 30mL/min/1.73m2 (Cockcroft-Gault formula) without the effects of dialysis therapy
Liver function
TBIL ≤ 1.5 x ULN; ALT and AST ≤ 2.5 x ULN
Cardiac function
Cardiac insufficiency ≥ grade 3 by NYHA classification; Myocardial infarction within 6 months; Poorly controlled angina within 6 months; Clinically significant arrhythmia; ECG QTcF >450 ms (men) and >470 ms (women); LVEF <50%
Hematologic fulfillment: ANC ≥ 1.0 x 10^9/L ... PLT ≥75 × 10^9/L ... Hemoglobin ≥ 80 g/L ... Liver and kidney function: TBIL ≤ 1.5 x ULN; ALT and AST ≤ 2.5 x ULN; GFR ≥ 30mL/min/1.73m2 ... Cardiac: Cardiac insufficiency ≥ grade 3 by NYHA classification; Myocardial infarction within 6 months; Poorly controlled angina within 6 months; Clinically significant arrhythmia; ECG QTcF >450 ms (men) and >470 ms (women); LVEF <50%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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