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

NCT ID: NCT04025450

Last Updated: 2019-07-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-15
• Study Completion Date: 2029-07-15

Brief 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.

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.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Chidamide plus 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

Group Type: EXPERIMENTAL

Chidamide+VRD

Intervention Type: DRUG

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

VRD

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

Group Type: ACTIVE_COMPARATOR

VRD

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Soochow University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

chengcheng Fu, PhD

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Suzhou University

Locations

First Affiliated Hospital, Soochow University

Suzhou, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Chengcheng Fu, PhD

Role: CONTACT

fuzhengzheng@suda.edu.cn

13962191404

Facility Contacts

Fu chengcheng, Phd

Role: primary

fuchengcheng@suda.edu.cn

13962191404

Other Identifiers

SZ-ChiVRD VS VRD-MM02

Identifier Type: -

Identifier Source: org_study_id