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

  • STATUS
    Recruiting
  • End date
    Jul 15, 2029
  • participants needed
    50
  • sponsor
    The First Affiliated Hospital of Soochow University
Updated on 23 January 2021
platelet count
dexamethasone
lenalidomide
neutrophil count
bortezomib
velcade
plasmacytoma

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.

Description

In the phase I trial, dose escalation of chidamide will be performed at 4 different dosages (15mg, 20mg, 25mg, 30mg) for optimal dosage, which will be determined by efficacy and safety profiles of the patients; afterward, the optimal dosage of chidamide will be combined with VRD regimen, patients will be randomly assigned to chidamide+VRD group or VRD group, and their efficacy and safety will be compared.

Details
Condition Multiple Myeloma, Lymphoproliferative Disorder, Lymphoproliferative disorders, multiple myeloma (mm)
Treatment Chidamide+VRD, VRD
Clinical Study IdentifierNCT04025450
SponsorThe First Affiliated Hospital of Soochow University
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnosed as multiple myeloma, and has one of the above
high risk karyotype, such as 17p-t414t1416t14201q 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%
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)
Age18 years, male or female
ECOG 0-2 points, with life expectance 3 months; GA score <2
ALT/AST level <2.5 times of the maximum of normal range; total bilirubin<1.5 times of normal maximum
Neutrophil count1.5109/L, platelet count50109/L
eGFR40ml/minexcept in the case of myeloma-related nephropathy
Normal left ventricular ejaculation rate, NYHA stage 1, pulmonary function GOLD stage 1
Willing to accept the possibility of potential adverse events and efficacy observation by the investigators
Being able to understand and signing the written consent, which should be signed prior to any procedure of the trial

Exclusion Criteria

With 2 degree of peripheral neuropath or with pain
Having received any of the medicine of the experiment regimen within 30 days prior to enrollment, pain-relieving radiotherapy is allowed
With severe pulmonary/cardiac disfunction (including history of QT interval elongation, ventricular tachycardia, ventricular fibrillation, myocardial infraction) or other severe organ malfunction
Patients in pregnancy or lactation
Allergic constitution or being allergic to any drug within the regimen of the trial
With uncontrolled mental diseases
With active infection
With non-myeloma-associated acute renal dysfunction
With active hepatitis
HIV positive
History of other malignant tumor within 5 years prior to enrollment; except for the case of in situ cervical cancer and non-malignant melanoma
With other conditions that the investigators think unfit for the trial
Clear my responses

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