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

Recruiting now · Phase 1/Phase 2

Conditions studied: Multiple Myeloma

In brief

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.

Key facts

Study ID: NCT04025450
Run by: The First Affiliated Hospital of Soochow University
People needed: 50
Starts: 2019-07-15
Expected to finish: 2029-07-15
Last updated by the study team: 2019-07-19

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

First Affiliated Hospital, Soochow University — Suzhou, Jiangsu, China (enrolling)

Full record on ClinicalTrials.gov

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