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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат 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
• Препарат VRD
  Velcade:1.3mg/m2 d1,d4,d8,d11/ Dexamethasone: 10mg BID d1,d2,d4,d5,d8,d9,d10,d11/Lenalidomide: 25mg d1-d14

Первичные конечные точки

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

Вторичные конечные точки (2)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• First Affiliated Hospital, Soochow University — Сучжоу

Идентификаторы

NCT: NCT04025450 · SZ-ChiVRD VS VRD-MM02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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