Actively Recruiting
An Open-Label Study to Evaluate Purinostat Mesylate Combined With Pomalidomide 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
8 weeks
Total Duration
On this page
AI-Summary
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 Ib/IIa 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 mg/m2, 6 mg/m2, and 8.4 mg/m2. 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 therapy's 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.
CONDITIONS
Brief 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 the Chinese Guidelines for Diagnosis and Treatment (Revised 2022)
- Have received at least one prior systemic antimyeloma therapy including lenalidomide and proteasome inhibitors
- Aged 18 to 75 years, male or female; females of childbearing potential must use effective contraception
- Have measurable M protein levels by serum, urine, or serum free light chain assay
- Meet blood count requirements: ANC ≥ 1.0 x 10^9/L, platelets ≥ 75 x 10^9/L (or ≥ 50 x 10^9/L with ≥ 50% plasma cells), hemoglobin ≥ 80 g/L
- Liver and kidney function within specified limits (TBIL ≤ 1.5 x ULN; ALT and AST ≤ 2.5 x ULN; GFR ≥ 30 mL/min/1.73m2)
- Able to receive antithrombotic medication
- ECOG performance status 0-2 and expected survival of at least 12 weeks
- Voluntarily agree to participate and sign informed consent
You will not qualify if you...
- Prior treatment with certain drugs including HDAC inhibitors (except cedarbenazine), antibody degradation agents, HSP90 inhibitors, or valproic acid
- Disease progression after prior standard dose pomalidomide treatment
- Allergic reactions to study drug components
- Diagnosis of non-secretory multiple myeloma, amyloidosis, or plasma cell leukemia
- Active new thrombosis or inability to receive antithrombotic therapy
- Other cancers within 5 years except certain cured or early-stage carcinomas
- Central nervous system disorders requiring treatment
- Peripheral neuropathy grade 3 or higher
- Long-term use of immunosuppressive drugs or steroids
- Active infectious diseases including hepatitis B, hepatitis C, HIV, or syphilis
- Significant cardiac conditions including recent myocardial infarction, uncontrolled angina, arrhythmias, prolonged QTc, or low ejection fraction
- Severe infections requiring intravenous antibiotics within 2 weeks
- Recent allogeneic stem cell transplant or active graft-versus-host disease
- Participation in another clinical trial within 4 weeks
- Recent antitumor therapy or major surgery without full recovery
- Pregnancy or breastfeeding
- Other factors making participation unsuitable such as uncontrolled hypertension, diabetes, poor adherence, or substance abuse
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 21-day or 28-day cycles until disease progression or discontinuation
Participants receive Purinostat Mesylate combined with Pomalidomide and low-dose Dexamethasone in cycles. Two treatment regimens are used: Regimen A consists of 21-day cycles with intravenous Purinostat Mesylate on Days 1, 4, 8, and 11, oral Pomalidomide daily for 14 days followed by 7 days off, and oral Dexamethasone on Days 1, 4, 8, and 11. Regimen B consists of 28-day cycles with intravenous Purinostat Mesylate on Days 1, 4, 15, and 18, oral Pomalidomide daily for 21 days followed by 7 days off, and oral Dexamethasone on Days 1, 4, 15, and 18.
Multiple visits each cycle for infusions and assessments
Trial Site Locations
Total: 1 location
1
West China Hospital Sichuan University
Chengdu, Sichuan, China, 610000
Actively Recruiting
Research Team
L
Liangkun Sun, bachelor
Z
Zheng Jiang, bachelor
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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