Comparation of Chidamide Plus VRD (Bortezomib, Lenalidomide, Dexamethasone) With VRD Regimen for Primary High-Risk Multiple Myeloma Patients, a Phase I/II, Multiple Center, Randomized Clinical Trial
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.
• 1.Diagnosed as multiple myeloma, and has one of the above:
‣ high risk karyotype, such as 17p-，t（4；14），t（14；16），t（14；20）或1q gain,1p-, double hit myeloma, triple hit myeloma, etc;
⁃ RISS-3;
⁃ IgD/IgE MM;
⁃ with measurable extra-medullary plasmacytoma;
⁃ flowcytometry showed peripheral blood plasma cell ≥0.165%；
• 2.Secretory MM should have measurable markers, including:
‣ specific M protein value (≥5g/L)；
⁃ and/or involved flc ≥100mg/L；
⁃ and/or measurable extramedullary foci (diameter\>1cm on CT);
• 3.Age≥18 years, male or female;
• 4.ECOG 0-2 points, with life expectance ≥3 months; GA score \<2;
• 5.ALT/AST level \<2.5 times of the maximum of normal range; total bilirubin\<1.5 times of normal maximum；
• 6.Neutrophil count≥1.5×109/L, platelet count≥50×109/L;
• 7.eGFR≥40ml/min，except in the case of myeloma-related nephropathy;
• 8.Normal left ventricular ejaculation rate, NYHA stage 1, pulmonary function GOLD stage 1;
• 9.Willing to accept the possibility of potential adverse events and efficacy observation by the investigators;
• 10.Being able to understand and signing the written consent, which should be signed prior to any procedure of the trial.