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

Phase 1

Recruiting

• Conditions: Multiple Myeloma
• Interventions: Drug: Chidamide+VRD; Drug: VRD

• Registration Number: NCT04025450
• Lead Sponsor: The First Affiliated Hospital of Soochow University

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.

Study Timeline

• Status Verified: 2019-07
• Study Start: 2019-07-15
• Study First Submitted: 2019-07-17
• Study First Submitted QC: 2019-07-17
• Last Update Submitted: 2019-07-17
• Study First Posted: 2019-07-19
• Last Update Posted: 2019-07-19
• Primary Completion: 2029-07-15
• Study Completion: 2029-07-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chidamide plus VRD	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	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

Name	Time	Method
complete remission rate	at the time point 1 month after the last cycle	complete remission rate after treated by the corresponding regimen
incidence and severity of adverse events	from the date of the start of treatment to 36 months after last patient's enrollment	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

Secondary Outcome Measures

Name	Time	Method
progression free survival	from the day of treatment to the date of first documented progression，up to 36 months after the last patient's enrollment;	from date of inclusion to date of progression, relapse, or death from any cause
overall survival	from the day of treatment to the date of first documented progression，up to 36 months after the last patient's enrollment	from the date of inclusion to date of death, irrespective of cause

Trial Locations

Locations (1)

First Affiliated Hospital, Soochow University; 🇨🇳 Suzhou, Jiangsu, China