Actively Recruiting
Purinostat Mesylate Combined With Pomalidomide Capsules and Low-dose Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma
Led by Chengdu Zenitar Biomedical Technology Co., Ltd · Updated on 2025-04-02
144
Participants Needed
1
Research Sites
105 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Purinostat Mesylate Combined With Pomalidomide Capsules and Low-dose Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with multiple myeloma according to Chinese Guidelines (Revised 2022)
- Received at least one prior systemic antimyeloma treatment including lenalidomide and proteasome inhibitors
- Age between 18 and 75 years, male or female; effective contraception required if of childbearing potential
- Measurable M protein by serum, urine, or serum free light chain levels
- Adequate hematologic function: ANC 61 1.0 x 10^9/L, platelets 61 75 x 10^9/L (or 61 50 x 10^9/L with 61 50% plasma cells), hemoglobin 61 80 g/L
- Liver and kidney function within specified limits: TBIL 64 1.5x ULN, ALT and AST 64 2.5x ULN, GFR 61 30 mL/min/1.73m2
- Ability to receive antithrombotic medications if needed
- ECOG performance status score of 0 to 2 and expected survival of at least 12 weeks
- Voluntary informed consent signed
You will not qualify if you...
- Prior treatment with HDAC inhibitors (except cedarbenazine), DAC, HSP90 inhibitors, or valproic acid; intolerance to similar drugs
- Disease progression after prior standard dose pomalidomide treatment
- Allergic reactions to study drug components
- Non-secretory multiple myeloma, amyloidosis, or plasma cell leukemia
- Active new thrombosis or inability to receive antithrombotic therapy
- Other malignancies within 5 years except certain cured cancers
- Central nervous system disorders requiring treatment
- Peripheral neuropathy grade 3 or higher
- Long-term immunosuppressive or steroid treatment
- Active infectious diseases including hepatitis B or C, HIV, or syphilis
- Significant cardiac conditions including recent myocardial infarction or severe arrhythmia
- Severe infections requiring intravenous antibiotics within 2 weeks prior to dosing
- Recent allogeneic stem cell transplant or active graft-versus-host disease
- Participation in another clinical trial within 4 weeks prior
- Recent antitumor therapy within 2 weeks prior
- Unresolved toxicities from prior therapy above grade 1 (except alopecia or malaise)
- Major surgery within 4 weeks without full recovery
- Pregnant or breastfeeding women
- Other factors judged unsuitable by the investigator such as uncontrolled hypertension or diabetes
AI-Screening
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Trial Site Locations
Total: 1 location
1
West China Hospital Sichuan University
Chengdu, Sichuan, China, 610000
Actively Recruiting
Research Team
L
Liangkun Sun, bachelor
CONTACT
Z
Zheng Jiang, bachelor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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