Actively Recruiting
Comparation of Chidamide Plus VRD (Bortezomib, Lenalidomide, Dexamethasone) With VRD Regimen for Primary High-Risk Multiple Myeloma Patients
Led by The First Affiliated Hospital of Soochow University · Updated on 2019-07-19
50
Participants Needed
1
Research Sites
521 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
In the phase I trial, dose escalation of chidamide will be performed at 4 different dosages (15mg, 20mg, 25mg, 30mg) for optimal dosage, in the phase II trial, the safety and efficacy of chidamide+VRD will be compared with that of VRD regimen.
CONDITIONS
Official Title
Comparation of Chidamide Plus VRD (Bortezomib, Lenalidomide, Dexamethasone) With VRD Regimen for Primary High-Risk Multiple Myeloma Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with multiple myeloma and one of the following: high-risk karyotype, RISS-3 stage, IgD/IgE type, measurable extramedullary plasmacytoma, or peripheral blood plasma cells ≥0.165%
- Secretory multiple myeloma with measurable markers including M protein ≥5g/L, involved free light chain ≥100mg/L, or measurable extramedullary lesions >1cm on CT
- Age 18 to 80 years, any gender
- ECOG performance status 0-2 with life expectancy of at least 3 months and GA score less than 2
- ALT/AST levels less than 2.5 times the upper normal limit; total bilirubin less than 1.5 times the upper normal limit
- Neutrophil count ≥1.5 x10⁹/L, platelet count ≥50 x10⁹/L
- Estimated glomerular filtration rate (eGFR) ≥40 ml/min except in myeloma-related kidney disease
- Normal left ventricular ejection fraction, NYHA class 1, and pulmonary function GOLD stage 1
- Willing to accept potential side effects and efficacy monitoring
- Able to understand and sign the informed consent form before any study procedures
You will not qualify if you...
- Having peripheral neuropathy of grade 2 or higher or pain
- Received any study regimen drug within 30 days before enrollment (pain-relieving radiotherapy allowed)
- Severe lung or heart problems including history of QT interval prolongation, ventricular arrhythmias, or heart attack, or other serious organ failure
- Pregnant or breastfeeding
- Allergic to any drugs in the study regimen
- Uncontrolled mental illness
- Active infection
- Non-myeloma-related acute kidney failure
- Active hepatitis
- HIV positive
- History of other cancers within 5 years except for in situ cervical cancer or non-malignant melanoma
- Any other condition deemed unsuitable by the investigators
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
First Affiliated Hospital, Soochow University
Suzhou, Jiangsu, China, 215000
Actively Recruiting
Research Team
C
Chengcheng Fu, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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