Recruiting NCT04025450

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

Phase I / Phase II Interventional Multiple Myeloma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Chidamide+VRD, VRD.
Who it may be relevant to: Registry conditions: Multiple Myeloma. Basic parameters: 18 years — 80 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: China
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed 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.

Interventions

Drug Chidamide+VRD
Chidamide:30mg d0,d3,d7,d10/Velcade:1.3mg/m2 d1,d4,d8,d11/ Dexamethasone: 10mg BID d1,d2,d4,d5,d8,d9,d10,d11/Lenalidomide: 25mg d1-d14
Drug VRD
Velcade:1.3mg/m2 d1,d4,d8,d11/ Dexamethasone: 10mg BID d1,d2,d4,d5,d8,d9,d10,d11/Lenalidomide: 25mg d1-d14

Primary outcome measures

complete remission rate [Time frame: at the time point 1 month after the last cycle]
incidence and severity of adverse events [Time frame: from the date of the start of treatment to 36 months after last patient's enrollment]

Secondary outcome measures (2)

progression free survival [Time frame: from the day of treatment to the date of first documented progression，up to 36 months after the last patient's enrollment;]
overall survival [Time frame: from the day of treatment to the date of first documented progression，up to 36 months after the last patient's enrollment]

Eligibility criteria

Inclusion criteria

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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Open label
Primary purpose: Treatment

Study locations

China · 1 center

First Affiliated Hospital, Soochow University — Suzhou

Identifiers

NCT: NCT04025450 · SZ-ChiVRD VS VRD-MM02

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗