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OncoMatch/Clinical Trials/NCT04025450

Comparation of Chidamide Plus VRD (Bortezomib, Lenalidomide, Dexamethasone) With VRD Regimen for Primary High-Risk Multiple Myeloma Patients

Is NCT04025450 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Chidamide+VRD and VRD for multiple myeloma.

Phase 1/2RecruitingThe First Affiliated Hospital of Soochow UniversityNCT04025450Data as of May 2026

Treatment: Chidamide+VRD · VRDIn 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.

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Extracted eligibility criteria

Cancer type

Multiple Myeloma

Disease stage

Required: Stage RISS-3 (RISS)

RISS-3

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: chidamide, bortezomib, lenalidomide, dexamethasone (any of the experimental regimen) (chidamide, bortezomib, lenalidomide, dexamethasone)

Exception: pain-relieving radiotherapy is allowed

Having received any of the medicine of the experiment regimen within 30 days prior to enrollment, pain-relieving radiotherapy is allowed

Lab requirements

Blood counts

Neutrophil count≥1.5×10^9/L, platelet count≥50×10^9/L

Kidney function

eGFR≥40ml/min, except in the case of myeloma-related nephropathy

Liver function

ALT/AST level <2.5 times of the maximum of normal range; total bilirubin<1.5 times of normal maximum

Cardiac function

Normal left ventricular ejection rate, NYHA stage 1

ALT/AST level <2.5 times of the maximum of normal range; total bilirubin<1.5 times of normal maximum; Neutrophil count≥1.5×10^9/L, platelet count≥50×10^9/L; eGFR≥40ml/min, except in the case of myeloma-related nephropathy; Normal left ventricular ejaculation rate, NYHA stage 1, pulmonary function GOLD stage 1

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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