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

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04025450
• Other study ID #: SZ-ChiVRD VS VRD-MM02
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: July 15, 2019
• Est. completion date: July 15, 2029

Study information

• Verified date: July 2019
• Source: The First Affiliated Hospital of Soochow University
• Contact: Chengcheng Fu, PhD
• Phone: 13962191404
• Email: fuzhengzheng[@]suda.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 15, 2029
• Est. primary completion date: July 15, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)?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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

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

Locations

Country	Name	City	State
China	First Affiliated Hospital, Soochow University	Suzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Soochow University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complete remission rate	complete remission rate after treated by the corresponding regimen	at the time point 1 month after the last cycle
Primary	incidence and severity of adverse events	any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure	from the date of the start of treatment to 36 months after last patient's enrollment
Secondary	progression free survival	from date of inclusion to date of progression, relapse, or death from any cause	from the day of treatment to the date of first documented progression,up to 36 months after the last patient's enrollment;
Secondary	overall survival	from the date of inclusion to date of death, irrespective of cause	from the day of treatment to the date of first documented progression,up to 36 months after the last patient's enrollment