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

Korábbi kezelés

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

Más betegség

• 5.Allergic constitution or being allergic to any drug within the regimen of the trial;
• 6.With uncontrolled mental diseases;
• 7.With active infection;
• 9.With active hepatitis;
• 10.HIV positive;
• 11.History of other malignant tumor within 5 years prior to enrollment; except for the case of in situ cervical cancer and non-malignant melanoma;
• 12.With other conditions that the investigators think unfit for the trial.

Laborértékek

• 3.With severe pulmonary/cardiac disfunction (including history of QT interval elongation, ventricular tachycardia, ventricular fibrillation, myocardial infraction) or other severe organ malfunction;

Egyéb

• 1.With ≥2 degree of peripheral neuropath or with pain;
• 4.Patients in pregnancy or lactation;
• 8.With non-myeloma-associated acute renal dysfunction;

• 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.