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

• Status: Recruiting
• Trial end date: 2029-07-15
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Affiliated Hospital of Soochow University
• Treatments: BB 1101; Bortezomib; Dexamethasone; Dexamethasone acetate; Lenalidomide

Criteria

Inclusion Criteria:

• 1.Diagnosed as multiple myeloma, and has one of the above:

1. 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;

2. RISS-3;

3. IgD/IgE MM;

4. with measurable extra-medullary plasmacytoma;

5. flowcytometry showed peripheral blood plasma cell ≥0.165%；

• 2.Secretory MM should have measurable markers, including:

1. specific M protein value (≥5g/L)；

2. and/or involved flc ≥100mg/L；

3. 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.

Exclusion Criteria:

• 1.With ≥2 degree of peripheral neuropath or with pain;

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

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

• 4.Patients in pregnancy or lactation;

• 5.Allergic constitution or being allergic to any drug within the regimen of the trial;

• 6.With uncontrolled mental diseases;

• 7.With active infection;

• 8.With non-myeloma-associated acute renal dysfunction;

• 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.